| | | | | |
| |
|
|
| Dockets Entered
On October 28, 2003
Table of Contents
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|
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|
| |
|
|
| Docket #
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| Title
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|
|
|
|
|
|
| 1994N-0418
|
| Order for Certain Class III Devices, including S&E info
|
| |
|
|
| 1994P-0286
|
| Amend Portions of the Canned Tuna "Standard"
|
| |
|
|
| 1996P-0276
|
| Reclassify Arrhythmia Detector and Alarm
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| 1998D-1146
|
| Microbial effects of antimicrobial new animal drugs/human sa
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| 1998P-0610
|
| Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC
|
| |
|
|
| 1999D-1938
|
| Development of Generic Drug Products
|
| |
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
| |
|
|
| 1999F-5321
|
| Food Safety & Inspection service safe use of ionizing radiai
|
| |
|
|
| 1999F-5322
|
| Ionizing Radiation for the Treatment of Food
|
| |
|
|
| 1999F-5522
|
| Ionizing radiation /control of Food-borne pathogens safe use
|
| |
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
| |
|
|
| 2000D-1598
|
| Voluntary Labeling for Bioengineered Foods
|
| |
|
|
| 2000P-1322
|
| Food Labeling and Allergen Contamination Control
|
| |
|
|
| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
|
| |
|
|
| 2002D-0421
|
| Arrhythmia Detector and Alarm from class III to class II
|
| |
|
|
| 2002H-0443
|
| Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care
|
| |
|
|
| 2002N-0276
|
| Bioterrorism Preparedness;Registration of Food Facilities
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| 2003D-0057
|
| How to use E-mail to submit a protocol
|
| |
|
|
| 2003D-0383
|
| Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
|
| |
|
|
| 2003M-0010
|
| PMA SIR-Spheres, P990065
|
| |
|
|
| 2003M-0011
|
| PMA Karl Storz Autofluorescence System, p020008
|
| |
|
|
| 2003M-0040
|
| PMA INDERMIL Tissue Adhesive, P010002
|
| |
|
|
| 2003M-0045
|
| PMA, Stockert 70 RF Generator for Cardiac Ablation, P990071
|
| |
|
|
| 2003M-0046
|
| pma Dimension FPSA Flex Reagent Cartridge & Dimension T/F PS
|
| |
|
|
| 2003M-0049
|
| PMA NaviStar DS & Celsius DS Diagnostic/Ablation Catheters
|
| |
|
|
| 2003M-0070
|
| PMA VERSANT HCV RNA Qualitative Assay, P020011
|
| |
|
|
| 2003M-0086
|
| Carpentier-Edwards S.A.V. Bioprosthesis Model 2650 (Aortic)
|
| |
|
|
| 2003M-0114
|
| CosmoDerm 1 Human-Based Collagen, CosmoDerm 2 Human-Based
|
| |
|
|
| 2003M-0115
|
| PMA NeedleZap, P010065
|
| |
|
|
| 2003M-0116
|
| Express & Express2 Monorail & Over-the-Wire Coronary Stent
|
| |
|
|
| 2003M-0122
|
| PMA BAK/Cervical (BAK/C) Interbody Fusion System, P980048
|
| |
|
|
| 2003N-0077
|
| Recognition List Number 008;FDA Moderdization Act of 1997; Modification of the Recognized Standards List
|
|
| | | | | | | | |
| |
|
|
| 2003N-0211
|
| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
|
| |
|
|
| 1994N-0418
|
| Order for Certain Class III Devices, including S&E info
|
| |
|
|
| NFR
2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| NI
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1994P-0286
|
| Amend Portions of the Canned Tuna "Standard"
|
| |
|
|
| EMC
1
Tables
|
| US Tuna Foundation
|
| Vol #:
|
| 1
|
| |
|
|
| 1996P-0276
|
| Reclassify Arrhythmia Detector and Alarm
|
| |
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 15
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET
11383
|
| Tyler Encapsulations
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11384
|
| Tyler Encapsulations
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11385
|
| Wellness International Network, Ltd.
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11386
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11387
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11388
|
| Soft Gel Technologies Inc.
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11389
|
| Optimum Nutrition
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11390
|
| Optimum Nutrition
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11391
|
| ProSynthesis Laboratories LLC
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11392
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11393
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11394
|
| Herbalife International of America, Inc.
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11395
|
| Barleans' Organic Oils, LLC
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11396
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11397
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11398
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11399
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11400
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 87
|
| |
|
|
| LET
11401
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 87
|
| |
|
|
| 1998D-1146
|
| Microbial effects of antimicrobial new animal drugs/human sa
|
| |
|
|
| GDL
2
|
| Guidance
|
| Vol #:
|
| 62
|
| |
|
|
| NAD
3
|
| FDA
|
| Vol #:
|
| 62
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
| | | | | | | |
| |
|
|
| EMC 3844
|
| No signature
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3845
|
| Alicia Crews
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3846
|
| Barb Matthes
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3847
|
| Tamara McPherson
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3848
|
| Vincent R. Fontanetta
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3849
|
| Roger Hinson
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3850
|
| Angela K. Walters & Donna M. Przytulski
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3851
|
| Stacy Byce
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3852
|
| Dawn Swoger
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3853
|
| Kathie Quisenberry
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3854
|
| Gerhild Paris
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3855
|
| Pat Driver
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3856
|
| Jan and Doug Kitzmiller
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3857
|
| Vanessa Wensing
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3858
|
| Kevin Halliez
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3859
|
| Karen Kunkel
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3860
|
| Shannon Teper
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3861
|
| Yelina Catron
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3862
|
| Seda Chitmon
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3863
|
| Rose Quaday
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3864
|
| Susan Traver
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3865
|
| Lynda Boehme
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3866
|
| Colleen Glass
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3867
|
| Jennifer K. Himes
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3868
|
| Nancy M. Southworth
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3869
|
| Karen Kirchdoerfer
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3870
|
| Nanci Gabbard
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3871
|
| Kathleen Peters
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3872
|
| Heather Williams
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3873
|
| Beverly Longuil
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3874
|
| Susan Miko
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3875
|
| Janet Bernardy
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3876
|
| Meghan Merryfield
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3877
|
| Marta Trombetta, MSW LSW
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3878
|
| Sana Jamil
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3879
|
| Lee Cali
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3880
|
| Judy Schulte
|
| Vol #:
|
| 281
|
|
| | | | | | | | |
| |
|
|
| EMC 3881
|
| Barbara Marciani
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3882
|
| Bonnie Redding
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3883
|
| Peter and Pamela Sabatini
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3884
|
| Char Muffitt
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3885
|
| Patricia Duran
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3886
|
| Billie B. Nixon
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3887
|
| No signature
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3888
|
| Dr. Beth E. Mestman
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3889
|
| Vivienne Handy
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3890
|
| Dorothy Wilson
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3891
|
| Claudia Bordin
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3892
|
| Thomas M. Vareha, Jr.
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3893
|
| A. Nendick
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3894
|
| Thomas M. Vareha, Jr.
|
| Vol #:
|
| 281
|
| |
|
|
| 1998P-0610
|
| Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC
|
| |
|
|
| EMC 97
|
| Peg Shannon
|
| Vol #:
|
| 5
|
| |
|
|
| 1999D-1938
|
| Development of Generic Drug Products
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
| |
|
|
| EMC 445
|
| Christine Miller
|
| Vol #:
|
| 8
|
| |
|
|
| 1999F-5321
|
| Food Safety & Inspection service safe use of ionizing radiai
|
| |
|
|
| EMC 348
|
| Christine Miller
|
| Vol #:
|
| 32
|
| |
|
|
| 1999F-5322
|
| Ionizing Radiation for the Treatment of Food
|
| |
|
|
| EMC 347
|
| Christine Miller
|
| Vol #:
|
| 6
|
| |
|
|
| 1999F-5522
|
| Ionizing radiation /control of Food-borne pathogens safe use
|
| |
|
|
| EMC 350
|
| Christine Miller
|
| Vol #:
|
| 6
|
| |
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
| |
|
|
| EMC 4063
|
| Augustin Parker
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 4064
|
| Vince Sherry
|
| Vol #:
|
| 514
|
| |
|
|
| EMC 4065
|
| Shannon Svensson
|
| Vol #:
|
| 514
|
| |
|
|
| EMC 4066
|
| Melanie E. Froning
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 4067
|
| Eileen Novak
|
| Vol #:
|
| 514
|
|
| | | | | | | | |
| |
|
|
| EMC 4068
|
| Lorraine Kleppe
|
| Vol #:
|
| 514
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| EMC 478
|
| Barbara Wilkie
|
| Vol #:
|
| 21
|
| |
|
|
| EMC 479
|
| No signature
|
| Vol #:
|
| 21
|
| |
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
| |
|
|
| EMC 567
|
| Sharon Tapper
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 568
|
| Ella Dicecca
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 569
|
| Marjie Gilliam
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 570
|
| Thomas Walker
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 571
|
| Leo Carling
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 572
|
| Lynn Grieger
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 573
|
| Maureen Dagg
|
| Vol #:
|
| 32
|
| |
|
|
| 2000D-1598
|
| Voluntary Labeling for Bioengineered Foods
|
| |
|
|
| EMC 12015
|
| Cindy and Gary Wilson
|
| Vol #:
|
| 574
|
| |
|
|
| 2000P-1322
|
| Food Labeling and Allergen Contamination Control
|
| |
|
|
| EMC 535
|
| Kim Steinke
|
| Vol #:
|
| 20
|
| |
|
|
| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
|
| |
|
|
| EMC 452
|
| Christine Miller
|
| Vol #:
|
| 8
|
| |
|
|
| 2002D-0094
|
| IND Exemptions for Studies of Lawfully Marketed Cancer Drugs
|
| |
|
|
| EC 3
|
| Oliver, Marlene
|
| Vol #:
|
| 1
|
| |
|
|
| 2002D-0421
|
| Arrhythmia Detector and Alarm from class III to class II
|
| |
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2002H-0443
|
| Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care
|
| |
|
|
| MO
15
|
| GCF-1, Patton Boggs LLP and Onebane Firm
|
| Vol #:
|
| 1
|
| |
|
|
| 2002N-0276
|
| Bioterrorism Preparedness;Registration of Food Facilities
|
| |
|
|
| EMC
100
|
| Australian Embassy
|
| Vol #:
|
| 15
|
| |
|
|
| NM
3
|
| FDA
|
| Vol #:
|
| 15
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| EMC
122
|
| Australian Embassy
|
| Vol #:
|
| 17
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| NM
3
|
| FDA
|
| Vol #:
|
| 17
|
| |
|
|
| 2003D-0057
|
| How to use E-mail to submit a protocol
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0165
|
| Current Good Manufacturing Practices for Medical Gases
|
| |
|
|
| EC 1
|
| Pulley, Steve
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0195
|
| Draft Guidance for Industry on Necessity of the Use of Food Product Categories in Registration of Food Facilities
|
| |
|
|
| EC 13
|
| RIVERA GONZALEZ, AIDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0290
|
| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
| |
|
|
| EC 3
|
| Hall, Carol
|
| Vol #:
|
| 1
|
| |
|
|
| EC 4
|
| Malanowski, Bobbi
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0367
|
| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
|
| |
|
|
| EC 1
|
| Jones, Allen
|
| Vol #:
|
| 1
|
| |
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| 2003D-0383
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| Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
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| |
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| GDL
1
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| Guidance
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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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| |
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| 2003M-0010
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| PMA SIR-Spheres, P990065
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| |
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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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| 2003M-0011
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| PMA Karl Storz Autofluorescence System, p020008
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| |
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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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| 2003M-0040
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| PMA INDERMIL Tissue Adhesive, P010002
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| |
|
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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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| 2003M-0045
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| PMA, Stockert 70 RF Generator for Cardiac Ablation, P990071
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| |
|
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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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| 2003M-0046
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| pma Dimension FPSA Flex Reagent Cartridge & Dimension T/F PS
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| |
|
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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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| 2003M-0049
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| PMA NaviStar DS & Celsius DS Diagnostic/Ablation Catheters
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| |
|
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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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| 2003M-0070
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| PMA VERSANT HCV RNA Qualitative Assay, P020011
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| |
|
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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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| 2003M-0086
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| Carpentier-Edwards S.A.V. Bioprosthesis Model 2650 (Aortic)
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| |
|
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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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| 2003M-0114
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| CosmoDerm 1 Human-Based Collagen, CosmoDerm 2 Human-Based
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| |
|
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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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| 2003M-0115
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| PMA NeedleZap, P010065
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| |
|
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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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| 2003M-0116
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| Express & Express2 Monorail & Over-the-Wire Coronary Stent
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| |
|
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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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| |
|
|
| 2003M-0122
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| PMA BAK/Cervical (BAK/C) Interbody Fusion System, P980048
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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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| 2003N-0077
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| Recognition List Number 008;FDA Moderdization Act of 1997; Modification of the Recognized Standards List
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| |
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| N
2
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| FDA
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| Vol #:
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| 1
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| |
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| 2003N-0211
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| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
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| |
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| EC 6
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| Nelson, Laura
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| Vol #:
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| 1
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| |
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| EC 7
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| Distler, Patricia
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| Vol #:
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| 1
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| EC 8
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| Berrio, Spica
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| Vol #:
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| 1
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| |
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| EC 9
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| Montrose, Scott
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| Vol #:
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| 1
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| |
|
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| NCR
1
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| FDA
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| Vol #:
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| 1
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| |
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| 2003N-0338
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| Obesity
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| |
|
|
| EC 31
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| Oliver, Marlene
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| Vol #:
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| 1
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| |
|
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| |
|
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| EC 6
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| Lindboe, John
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| Vol #:
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| 3
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| |
|
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| EC 7
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| Schreiner, Janine
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| Vol #:
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| 3
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| |
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| EC 8
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| Monahan, Gene
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| Vol #:
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| 3
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| EC 9
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| Verbeek, Dirk
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| Vol #:
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| 3
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| |
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| EC 10
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| Holness, David A
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| Vol #:
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| 3
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| |
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| EC 11
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| Heinio, Jan
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| Vol #:
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| 3
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