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| Dockets Entered
On May 12, 2004
Table of Contents
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| Docket #
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| Title
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| 1998P-0620
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| Withdrawn Protocol Review Pkg for Amiodarone HCL Tablets
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| |
|
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| 2002N-0532
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| Nonclinical Datasets; Notice of Pilot Project
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| |
|
|
| 2003D-0553
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| Guidance on Developing Drugs to Mitigate the Complications Associated With Vaccinia Virus Used for Smallpox Vaccination
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| |
|
|
| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| |
|
|
| 2003M-0242
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| Zenith AAA Endovascular Graft and H&L-B One-Shot Introduction System, P020018
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| |
|
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| 2003M-0305
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| Premarket Approval for Dermagraft, Human Fibroblast-Derived Dermal Substitute, H020004
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| |
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| 2003M-0320
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| Premarket Approval, FX miniRAIL, Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter,P020037
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| |
|
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| 2003M-0332
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| P010001, Ceramic TRANSCEND Hip Articulation System, Approved 2/3/03
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| 2003M-0333
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| STAR S4 ActiveTrak Excimer Laser System and WaveScan WaveFront System
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| 2003M-0337
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| P000013 - Osteonics ABC System and Trident System
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| 2003M-0339
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| P020002 - ThinPrep Imaging System
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|
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| 2003M-0343
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| Premarket Approval, P020052 - Response CV Catheter System, Approved 5/7/03
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| 2003M-0352
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| PMA P020049, ProCol Vascular Bioprosthesis
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| 2003M-0356
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| PMA P030027 - Ceramic TRANSCEND Hip Articulation System
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| |
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| 2003M-0375
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| P020033 - INDEPENDENCE iBOT 3000 Mobility System, Approved 8/13/03
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| |
|
|
| 2003M-0381
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| P020036 - S.M.A.R.T. Nitinol Stent System and S.M.A.R.T. Control Nitinol Stent System
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| |
|
|
| 2003M-0427
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| Premarket Approval, P020025 - EP Technologies EPT-1000 XP RF Ablation System
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| |
|
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| 2003M-0487
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| P020007 - Medtronic AVE Bridge Extra Support Over-the-Wire (OTW) Renal Stent System
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| |
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| 2003M-0488
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| P020041- FemCap Barrier Contraceptive
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| |
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| 2003M-0490
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| P030009 - Medtronic Vascular Driver Over-the-Wire, Rapid Exchange, and Multi-Exchange Coronary Stent Systems
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| |
|
|
| 2003M-0491
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| P020050 - WaveLight ALLEGRETTO WAVE Excimer Laser System
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| |
|
|
| 2003M-0492
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| P030008 - WaveLight ALLEGRETTO WAVE Excimer Laser System
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| |
|
|
| 2003M-0499
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| P020047 - MULTI-LINK RX and OTW VISION Coronary Stent Systems
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| |
|
|
| 2003M-0524
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| P020040 - NIRflex Pre-mounted Coronary Stent System
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| |
|
|
| 2003M-0532
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| Premarket Approval P000028 - AFFINITY Cage System
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| |
|
|
| 2003M-0533
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| P990027/S006 - Bausch & Lomb TECHNOLAS 217z Zyoptix System for Personalized Vision Correction
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| |
|
|
| 2003M-0536
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| HDE Number: H020003, CONTEGRA Pulmonary Valved Conduit
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| |
|
|
| 2003M-0560
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| P030039, CoSeal Surgical Sealant
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| |
|
|
| 2003M-0569
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| Premarket Approval, D980003, Keramos Ceramic/Ceramic Total Hip System
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| |
|
|
| 2003N-0539
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| Over-the-Counter Drug Products; Safety and Efficacy Review
|
| |
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
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| |
|
|
| 2003P-0494
|
| Not approve any new drug application (NDA) for a hyaluronidase product unless the conditions set forth in the petition are satisfied
|
| |
|
|
| 2003P-0501
|
| Pyridostigmine Bromide Tablets, 30mg for the of myasthenia gravis (ANDA) voluntarily withdrawn from sale for safety or efficacy reasons
|
| |
|
|
| 2003P-0518
|
| Refrain from approving any Abbreviated New Drug Application for sirolimus with Rapamune (sirolimus)
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| |
|
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| |
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| |
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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|
| | | | | | | | |
| |
|
|
| 2004N-0086
|
| Diabetes: Targeting Safe and Effective Prevention and Treatment; Public Meeting
|
| |
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
| |
|
|
| 2004N-0194
|
| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
|
| |
|
|
| 2004N-0205
|
| Furan in food; thermal treatment
|
| |
|
|
| 2004P-0008
|
| Protection from Chlorinated Dibenzo-p-dioxins and Chlorodibenzofurans
|
| |
|
|
| 2004P-0139
|
| approval of generic versions of Concerta (methylphenidate HCI extended-release tablets are both bioequivalent and clinically equivalent to the innovator product
|
| |
|
|
| 2004P-0223
|
| Whole Grain Descriptive Claims
|
| |
|
|
| 2004P-0225
|
| NDA 21-259 Metadate CD Extended-Release Capsules
|
| |
|
|
| 2004Q-0201
|
| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
|
| |
|
|
| 1998P-0620
|
| Withdrawn Protocol Review Pkg for Amiodarone HCL Tablets
|
| |
|
|
| WDL
1
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| Wyeth Pharmaceuticals
|
| Vol #:
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| 4
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| |
|
|
| 2002N-0532
|
| Nonclinical Datasets; Notice of Pilot Project
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| |
|
|
| LET
4
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| Aventis Inc.
|
| Vol #:
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| 1
|
| |
|
|
| 2003D-0553
|
| Guidance on Developing Drugs to Mitigate the Complications Associated With Vaccinia Virus Used for Smallpox Vaccination
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| |
|
|
| C
1
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| Chimerix, Inc.
|
| Vol #:
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| 1
|
| |
|
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| |
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| CS
6
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| HFA-035
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| Vol #:
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| 2
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| |
|
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| OR
6
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| HF-3
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| Vol #:
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| 2
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| |
|
|
| 2003M-0242
|
| Zenith AAA Endovascular Graft and H&L-B One-Shot Introduction System, P020018
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| |
|
|
| N
1
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| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003M-0305
|
| Premarket Approval for Dermagraft, Human Fibroblast-Derived Dermal Substitute, H020004
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003M-0320
|
| Premarket Approval, FX miniRAIL, Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter,P020037
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003M-0332
|
| P010001, Ceramic TRANSCEND Hip Articulation System, Approved 2/3/03
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| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003M-0333
|
| STAR S4 ActiveTrak Excimer Laser System and WaveScan WaveFront System
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003M-0337
|
| P000013 - Osteonics ABC System and Trident System
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
|
| | | | | | | | |
| |
|
|
| 2003M-0339
|
| P020002 - ThinPrep Imaging System
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003M-0343
|
| Premarket Approval, P020052 - Response CV Catheter System, Approved 5/7/03
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003M-0352
|
| PMA P020049, ProCol Vascular Bioprosthesis
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003M-0356
|
| PMA P030027 - Ceramic TRANSCEND Hip Articulation System
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0375
|
| P020033 - INDEPENDENCE iBOT 3000 Mobility System, Approved 8/13/03
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0381
|
| P020036 - S.M.A.R.T. Nitinol Stent System and S.M.A.R.T. Control Nitinol Stent System
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| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003M-0427
|
| Premarket Approval, P020025 - EP Technologies EPT-1000 XP RF Ablation System
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003M-0487
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| P020007 - Medtronic AVE Bridge Extra Support Over-the-Wire (OTW) Renal Stent System
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003M-0488
|
| P020041- FemCap Barrier Contraceptive
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003M-0490
|
| P030009 - Medtronic Vascular Driver Over-the-Wire, Rapid Exchange, and Multi-Exchange Coronary Stent Systems
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003M-0491
|
| P020050 - WaveLight ALLEGRETTO WAVE Excimer Laser System
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003M-0492
|
| P030008 - WaveLight ALLEGRETTO WAVE Excimer Laser System
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0499
|
| P020047 - MULTI-LINK RX and OTW VISION Coronary Stent Systems
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0524
|
| P020040 - NIRflex Pre-mounted Coronary Stent System
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0532
|
| Premarket Approval P000028 - AFFINITY Cage System
|
|
| | | | | | | | |
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0533
|
| P990027/S006 - Bausch & Lomb TECHNOLAS 217z Zyoptix System for Personalized Vision Correction
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0536
|
| HDE Number: H020003, CONTEGRA Pulmonary Valved Conduit
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0560
|
| P030039, CoSeal Surgical Sealant
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0569
|
| Premarket Approval, D980003, Keramos Ceramic/Ceramic Total Hip System
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0539
|
| Over-the-Counter Drug Products; Safety and Efficacy Review
|
| |
|
|
| C
1
|
| Cosmetic, Toiletry and Fragrance Assn (CTFA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
| |
|
|
| C 72
|
| M. Vandenburg
|
| Vol #:
|
| 6
|
| |
|
|
| 2003P-0494
|
| Not approve any new drug application (NDA) for a hyaluronidase product unless the conditions set forth in the petition are satisfied
|
| |
|
|
| PDN
1
Table of Contents
References
|
| HFD-001 to Baxter Healthcare Corporation
|
| Vol #:
|
| 2
|
| |
|
|
| 2003P-0501
|
| Pyridostigmine Bromide Tablets, 30mg for the of myasthenia gravis (ANDA) voluntarily withdrawn from sale for safety or efficacy reasons
|
| |
|
|
| LET
1
|
| HFD-005 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0518
|
| Refrain from approving any Abbreviated New Drug Application for sirolimus with Rapamune (sirolimus)
|
| |
|
|
| LET
1
|
| HFD-005 to Covington & Burling
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
|
| |
|
|
| C 35
|
| H. McAllister
|
| Vol #:
|
| 2
|
| |
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
| |
|
|
| C 13
|
| J. Hale
|
| Vol #:
|
| 2
|
| |
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
|
| |
|
|
| C
16
|
| American Medical Assn (AMA)
|
| Vol #:
|
| 2
|
| |
|
|
| C
17
|
| Our Bodies Ourselves
|
| Vol #:
|
| 2
|
| |
|
|
| C
18
|
| Aventis Pharmaceuticals, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| C
19
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 2
|
| |
|
|
| C
20
Tabs
|
| Catalina Health Resource (CHR)
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
| |
|
|
| C
21
|
| Advertising Standards Authority, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| C
22
|
| Women and Health Protection
|
| Vol #:
|
| 2
|
| |
|
|
| C
23
|
| Bristol Myers Squibb Company
|
| Vol #:
|
| 2
|
| |
|
|
| C
24
|
| UCSF Center for Consumer Self Care (the Center)
|
| Vol #:
|
| 2
|
| |
|
|
| C
25
Attachments
|
| City and County of San Francisco
|
| Vol #:
|
| 2
|
| |
|
|
| C
26
|
| Staff of Bureau of Consumer Protection,the Bureau of Economics,the Office of Policy Planning of FTC
|
| Vol #:
|
| 2
|
| |
|
|
| C
27
|
| National Consumers League
|
| Vol #:
|
| 2
|
| |
|
|
| 2004N-0086
|
| Diabetes: Targeting Safe and Effective Prevention and Treatment; Public Meeting
|
| |
|
|
| C
3
|
| Diabetes and Endocrine Associates
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
| |
|
|
| APE 13
|
| SEC Associates, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| APE 14
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
| |
|
|
| APE 15
|
| Triangle Peers
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0194
|
| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
|
| |
|
|
| NPR
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0205
|
| Furan in food; thermal treatment
|
| |
|
|
| BKG 1
|
| Background Material
|
| Vol #:
|
| 1
|
| |
|
|
| NRD
1
|
| FDA
|
| Vol #:
|
| 2
|
| |
|
|
| 2004P-0008
|
| Protection from Chlorinated Dibenzo-p-dioxins and Chlorodibenzofurans
|
| |
|
|
| C 1
|
| Form Letters
|
| Vol #:
|
| 2
|
| |
|
|
| 2004P-0139
|
| approval of generic versions of Concerta (methylphenidate HCI extended-release tablets are both bioequivalent and clinically equivalent to the innovator product
|
| |
|
|
| C
1
|
| Celltech Americas, Inc.
|
| Vol #:
|
| 4
|
| |
|
|
| 2004P-0223
|
| Whole Grain Descriptive Claims
|
| |
|
|
| ACK
1
|
| HFA-305 to Patton Boggs LLP
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| General Mills, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0225
|
| NDA 21-259 Metadate CD Extended-Release Capsules
|
| |
|
|
| ACK 1
|
| HFA-305 to Celltech Americas, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Celltech Americas, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004Q-0201
|
| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
|
|
| |
|
| ACK
1
|
| HFS-830 to Emord & Associates, PC
|
| Vol #:
|
| 16
|
| |
|
|
| LET
1
|
| American Longevity, Inc
|
| Vol #:
|
| 16
|
|
| | | | | | | |
| |
|
|
| QHC
1
|
| American Longevity, Inc
|
| Vol #:
|
| 1
|
|
|
