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| Dockets Entered
On December 23, 2004
Table of Contents
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| Docket #
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| Title
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| 2002N-0277
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| Bioterrorism; Establishment & Maintenance of Records
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| 2003M-0172
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| PMA Cypher Sirolimus-Eluting Coronary Stent on the Raptor
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| 2003P-0531
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| Issue a report providing the necessary information on pill weight tolerances and/or variations caused by reformulations
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| 2004D-0327
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| Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| 2004D-0453
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| Compliance Policy Guide Sec. 560.400 - "Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)"
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| 2004G-0381
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| Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2004M-0309
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| P020023 - Restylane Injectable Gel
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| 2004M-0310
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| P020030 - Stelid II steroid eluting pacing leads, Approved 6/17/04
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| 2004M-0312
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| P970043/S015- LADARVision 4000 Excimer Laser System, Approved 6/29/04
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| 2004M-0313
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| P030054 - St. Jude Medical Epic HF System, Approved 6/30/04
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| 2004M-0323
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| Premarket Approval for ImageChecker CT CAD Software System - Model LN-1000 by R2 Technology, Inc., Approved 7/8/04 (P030012)
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| 2004M-0341
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| P030024 - Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator
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| 2004M-0342
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| P040008 - VIDAS TPSA assay
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| 2004M-0345
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| Premarket Approval for CureLight BroadBand by PhotoCure ASA (Model CureLight 01) P010061
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| 2004M-0350
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| Premarket Approval for Sculptra - P030050
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| 2004M-0356
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| P030026 - Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator
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| 2004M-0387
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| P030010 - Siemens Mammomat Novation Full Field Digital Mammography System,
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| 2004M-0388
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| P040012 - ACCULINK Carotid Stent System and RX ACCULIN Carotid Stent System
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| 2004M-0403
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| P030025 - TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire)
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| 2004M-0415
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| H030009 - Vertical Expandable Prosthetic Titanium Rib (VEPTR)
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| 2004M-0430
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| P010012/S026 - CONTAK CD (Model 1823), CONTAK CD 2 (Models H115 and H119), RENEWAL (Model H135), RENEWAL 3 (Models H170, H175, H177, and H179)
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| 2004M-0433
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| P030044 - DakoCytomation EGFR pharmDx
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| 2004N-0479
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| Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability
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| 2004P-0519
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| Cottage Cheese Deviating from Identity Standard; Temporary Permit for Market Testing
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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| 2002N-0277
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| Bioterrorism; Establishment & Maintenance of Records
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| BKG
2
References
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| References 1 - 29
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| Vol #:
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| 20
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| NFR
1
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| FDA
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| Vol #:
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| 19
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| NM
2
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| FDA
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| Vol #:
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| 16
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| BKG
1
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| Background Material Refs 1 - 4
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| Vol #:
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| 1
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2003M-0172
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| PMA Cypher Sirolimus-Eluting Coronary Stent on the Raptor
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2003P-0531
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| Issue a report providing the necessary information on pill weight tolerances and/or variations caused by reformulations
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| LET
2
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| Fulcrum Inc.
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| Vol #:
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| 1
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| 2004D-0327
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| Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| C 8
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| J. Bencharsky
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| Vol #:
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| 1
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| C 9
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| C. Ristad
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| Vol #:
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| 1
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| C 10
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| J. Wright
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| Vol #:
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| 1
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| C 11
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| D. Shelton
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| Vol #:
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| 1
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| C 12
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| W. Rougle
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| Vol #:
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| 1
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| C 13
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| H. Koelle
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| Vol #:
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| 1
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| C 14
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| C. Whitney
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| Vol #:
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| 1
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| C 15
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| Form Letters
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| Vol #:
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| 3
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| C 16
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| Form Letters
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| Vol #:
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| 4
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| C 17
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| Form Letters
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| Vol #:
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| 5
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| C 18
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| Form Letters
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| Vol #:
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| 6
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| C
3
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| Animal Health Institute (AHI)
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| Vol #:
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| 1
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| C
4
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| ISPE
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| Vol #:
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| 1
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| C
5
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 1
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| C
6
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| Genentech
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| Vol #:
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| 1
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| C
7
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| Aventis Pasteur Inc.
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| Vol #:
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| 1
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| C
8
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| Bristol-Myers Squibb Company (BMS)
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| Vol #:
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| 1
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| C
16
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| Active Pharmaceutical Ingredients Committee (APIC)
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| Vol #:
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| 2
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| 2004D-0453
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| Compliance Policy Guide Sec. 560.400 - "Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)"
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| C
6
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| National Farmers Oraganization (NFO)
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| Vol #:
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| 1
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| | | | | | | | |
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| 2004G-0381
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| Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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|
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0309
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| P020023 - Restylane Injectable Gel
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0310
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| P020030 - Stelid II steroid eluting pacing leads, Approved 6/17/04
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0312
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| P970043/S015- LADARVision 4000 Excimer Laser System, Approved 6/29/04
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0313
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| P030054 - St. Jude Medical Epic HF System, Approved 6/30/04
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0323
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| Premarket Approval for ImageChecker CT CAD Software System - Model LN-1000 by R2 Technology, Inc., Approved 7/8/04 (P030012)
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0341
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| P030024 - Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0342
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| P040008 - VIDAS TPSA assay
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0345
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| Premarket Approval for CureLight BroadBand by PhotoCure ASA (Model CureLight 01) P010061
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0350
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| Premarket Approval for Sculptra - P030050
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0356
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| P030026 - Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0387
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| P030010 - Siemens Mammomat Novation Full Field Digital Mammography System,
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0388
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| P040012 - ACCULINK Carotid Stent System and RX ACCULIN Carotid Stent System
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0403
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| P030025 - TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire)
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| N
1
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| FDA
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| Vol #:
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| 1
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| | | | | | | | |
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| 2004M-0415
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| H030009 - Vertical Expandable Prosthetic Titanium Rib (VEPTR)
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0430
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| P010012/S026 - CONTAK CD (Model 1823), CONTAK CD 2 (Models H115 and H119), RENEWAL (Model H135), RENEWAL 3 (Models H170, H175, H177, and H179)
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0433
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| P030044 - DakoCytomation EGFR pharmDx
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| C
2
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| Kettering Medical Center
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| Vol #:
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| 2
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| EXT
3
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| Washington University in St. Louis
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| Vol #:
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| 2
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| EXT
4
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| University of Southern California (USC)
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| Vol #:
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| 2
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| 2004N-0479
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| Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability
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| EXT
1
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| Phibro Animal Health
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| Vol #:
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| 1
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| 2004P-0519
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| Cottage Cheese Deviating from Identity Standard; Temporary Permit for Market Testing
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| C
1
Enclosure
A, B
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| Eon Labs
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| Vol #:
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| 1
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