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| Dockets Entered
On January 13, 2006
Table of Contents
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| Docket #
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| Title
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| 1998D-0834
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| Non-Contraceptive
Estrogen Class Labeling
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| 2000P-0586
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| Amend Pt 133.3 re:Milk
and Nonfat Milk for use in Standardiz
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| 2003P-0132
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| Part 135 FDA regulations
standard of identity frozen dessert
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| 2004D-0156
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| International Cooperation
on Harmonization of Technical Requirements for Registration of Veterinary
Medicinal Products (VICH); Guidance for Industry on b
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| 2005D-0468
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| Guidance for Industry
and Food and Drug Administration Staff; Class II Special Controls
Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological
Assays
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| 2005M-0270
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| P030049 - ADVIA Centaur
HBsAg ReadyPack Reagents, ADVIA Centaur HBsAg Confirmatory ReadyPack
Reagents, and ADVIA Centaur HBsAg Quality Control Material - Approved
5/31/05
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| 2005M-0283
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| Premarket Approcal
of VNS Theraphy System Cyberonics, Inc. P970003/S050
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| 2005M-0284
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| Onco-LIFE Endoscopic
Light Source and Video Camera (Onco-LIFE) by Xillix Technologies Corp.,
P950042/S003, Approved 6/30/05
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| 2005M-0289
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| Premarket Approval
for St. Jude Medical Frontier TM Model 5508L & Frontier TM II
Model 5586 Cardiac Resynchronization Therapy Pacemakers, P030035/S003
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| 2005M-0308
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| H050001; Wingspan
Stent System with Gateway PTA Balloon Catheter
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| 2005M-0320
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| P040043 - GORE TAG
Thoracic Endoprosthesis
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| 2005M-0321
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| P040021 - SJM Biocor
Valve and SJM Biocor Supra Valve
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| 2005M-0328
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| P030004 - Onyx Liquid
Embolic System (LES),
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| 2005M-0339
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| Premarket Approval
for Orthometrix, Inc., Orbasone Pain Relief System (P040039)
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| 2005M-0359
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| P040044 - Matrix VSG
System, Model MX-100
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| 2005M-0378
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| P930014/S015 - ACRYSOF
Toric Posterior Chamber Intraocular Lens, Approved 9/14/05
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| 2005M-0379
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| P040037 - GORE VIABAHN
Endoprosthesis, Approved 6/14/05
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| 2005M-0380
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| P030036 - SelectSecure
Lead Model 3830, Approved 8/3/05
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| 2005M-0381
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| P040038 - Xact Carotid
Stent System, Approved 9/6/05
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| 2005M-0382
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| P930016/S021 - STAR
S4 IR Excimer Laser System with Variable Spot Scanning (VSS) and WaveScan
WaveFront System, Approved 8/30/05
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| 2005M-0387
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| P040005 - DakoCytomation
Her2 FISH pharmDx Kit, Approved 5/3/05
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| 2005M-0388
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| P040011 - DakoCytomation
c-Kit pharmDx, Approved 6/27/05
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| 2005N-0262
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| Submission of Chemistry,
Manufacturing, and Controls Information in a New Drug Application
Under the New Pharmaceutical Quality Assessment System; Notice of
Pilot Program
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| 2005N-0471
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| Immunology and Microbiology
Devices: Reclassification of Herpes Simplex Virus (Types 1 and/or
2) Serological Assays
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| 2005N-0479
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| International
Drug Scheduling; Convention on Psychotropic Substances; Single Convention
on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol);
Gamma-Hydroxybutyric Acid; Ketamine;
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| 2005N-0507
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| Agency Emergency Processing
Under OMB Review; Guidance on Informed Consent for In Vitro Diagnostic
Device Studies Using Leftover Human Specimens that are Not Individually
Identifiable
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| 2005N-0508
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| Agency Information
Collection Activities; Proposed Collection; Comment Request; Survey
of Healthcare Practitioners Regarding their Preferences for Public
Health Notifications
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| 2005P-0411
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| Seeking FDA Actions
to Counter Flagrant Violations of the Law by Pharmacies Compounding
Bio-Identical Hormone Replacement Therapy Drugs
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| 2006P-0030
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| 513 (e) Reclassification
tissue adhesive for soft tissue approximation
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| 2006V-0027
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| Laser Light Show regarding
GCO-1A and GCP-2
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| 1998D-0834
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| Non-Contraceptive
Estrogen Class Labeling
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| C
19
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| Novartis Pharmaceuticals
Corporation (Novartis)
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| Vol #:
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| 7
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| 2000P-0586
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| Amend Pt 133.3
re:Milk and Nonfat Milk for use in Standardiz
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| C
78
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| T.C. Jacoby and Company,
Inc. (TCJ)
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| Vol #:
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| 2
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| C
79
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| California Dairies, Inc. (CDI)
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| Vol #:
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| 2
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| C 44
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| C. Gross
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| Vol #:
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| 2
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| 2004D-0156
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| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Guidance for Industry on b
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| GDL
2
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| Guidance
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2005D-0468
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
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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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| 2005M-0270
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| P030049 - ADVIA Centaur HBsAg ReadyPack Reagents, ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur HBsAg Quality Control Material - Approved 5/31/05
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0283
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| Premarket Approcal of VNS Theraphy System Cyberonics, Inc. P970003/S050
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| NAL
1
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| FDA
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| Vol #:
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| 1
|
|
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|
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| 2005M-0284
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| Onco-LIFE Endoscopic Light Source and Video Camera (Onco-LIFE) by Xillix Technologies Corp., P950042/S003, Approved 6/30/05
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|
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| NAL
1
|
| FDA
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| Vol #:
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| 1
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| 2005M-0289
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| Premarket Approval for St. Jude Medical Frontier TM Model 5508L & Frontier TM II Model 5586 Cardiac Resynchronization Therapy Pacemakers, P030035/S003
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0308
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| H050001; Wingspan Stent System with Gateway PTA Balloon Catheter
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0320
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| P040043 - GORE TAG Thoracic Endoprosthesis
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0321
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| P040021 - SJM Biocor Valve and SJM Biocor Supra Valve
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|
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| NAL
1
|
| FDA
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| Vol #:
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| 1
|
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| 2005M-0328
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| P030004 - Onyx Liquid Embolic System (LES),
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| NAL
1
|
| FDA
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| Vol #:
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| 1
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| 2005M-0339
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| Premarket Approval for Orthometrix, Inc., Orbasone Pain Relief System (P040039)
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|
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| NAL
1
|
| FDA
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| Vol #:
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| 1
|
|
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| 2005M-0359
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| P040044 - Matrix VSG System, Model MX-100
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| | | | | | | | |
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| |
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| NAL
1
|
| FDA
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| Vol #:
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| 1
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| 2005M-0378
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| P930014/S015 - ACRYSOF Toric Posterior Chamber Intraocular Lens, Approved 9/14/05
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| NAL
1
|
| FDA
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| Vol #:
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| 1
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| |
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| 2005M-0379
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| P040037 - GORE VIABAHN Endoprosthesis, Approved 6/14/05
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0380
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| P030036 - SelectSecure Lead Model 3830, Approved 8/3/05
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0381
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| P040038 - Xact Carotid Stent System, Approved 9/6/05
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| NAL
1
|
| FDA
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| Vol #:
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| 1
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| 2005M-0382
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| P930016/S021 - STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS) and WaveScan WaveFront System, Approved 8/30/05
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|
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| NAL
1
|
| FDA
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| Vol #:
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| 1
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| 2005M-0387
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| P040005 - DakoCytomation Her2 FISH pharmDx Kit, Approved 5/3/05
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| NAL
1
|
| FDA
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| Vol #:
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| 1
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| 2005M-0388
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| P040011 - DakoCytomation c-Kit pharmDx, Approved 6/27/05
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| NAL
1
|
| FDA
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| Vol #:
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| 1
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| LET 4
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| Wyeth Pharmaceuticals (wyeth)
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| Vol #:
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| 3
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| |
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| 2005N-0471
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| Immunology and Microbiology Devices: Reclassification of Herpes Simplex Virus (Types 1 and/or 2) Serological Assays
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| NPR
1
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| FDA
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| Vol #:
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| 1
|
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| 2005N-0479
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma- Hydroxybutyric Acid; Ketamine;
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| C
3
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| Solvay Pharmaceuticals
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| Vol #:
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| 1
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| C
4
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| Purdue Pharma L.P. and Schering-Plough Corporation
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| Vol #:
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| 1
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| C
5
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| PriCara
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| Vol #:
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| 1
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| 2005N-0507
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| Agency Emergency Processing Under OMB Review; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
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| N
1
|
| FDA
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| Vol #:
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| 1
|
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| 2005N-0508
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Healthcare Practitioners Regarding their Preferences for Public Health Notifications
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|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
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|
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| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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|
