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Dockets Management

Dockets Entered On November 7, 2007 - Corrected Copy
Docket # Title
1978N-0038 Sunscreen Drug Products
2005N-0272 Irradiation in the Production, Processing & Handling of Food
2006D-0480 Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food D Drug Administration
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2007D-0249 Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
2007E-0440 Patent Term Extension Application for SYMBICORT Inhalation Aerosol (formoterol fumarate dihydrate and budesonide), U.S. Patent No. 5,674,860
2007M-0380 P070009 - REALIZE Adjustable Gastric Band
2007M-0408 P000009/S004 - Tachos DR Atrial Tx Implantable Cardioverter Defibrillator (ICD) System
2007M-0409 P060005 - IMMULITE/IMMULITE 1000 Free PSA Assay and IMMULITE/IMMULITE 2000 Free PSA Assay
2007M-0410 P060038 - Mitroflow Aortic Pericardial Heart Valve
2007M-0411 P070012 - Exponent Self-Expanding Carotid Stent System with Over-the-Wire or Rapid-Exchange Delivery System
2007M-0413 P060017 - GeneSearch Breast Lymph Node (BLN) Assay
2007M-0415 Humanitarian Device Exemption Approval for Epicel cultured epidermal autograft (CEA) H990002 by Genzyme Biosurgery
2007N-0277 Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
2007P-0235 Change the labeling requirements for eggs sold in the United States
2007V-0441 GCP-2C (V-2) Variance Application for Night Vision System
1978N-0038 Sunscreen Drug Products
C 620 A. Kongsiri Vol #: 162
C 621 Blue Ridge Aesthetics Center Vol #: 162
C 622 Commonwealth of Virginia Senate Vol #: 162
C 623 The Senate State of New York Vol #: 162
C 624 The Senate State of New York Vol #: 162
C 625 S. Webster Vol #: 162
2005N-0272 Irradiation in the Production, Processing & Handling of Food
C 3749 Dr. Terri Gibbs Vol #: 61
2006D-0480 Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food D Drug Administration
C 1435 R.J. Multhauf Vol #: 61
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 485 C. Cavins Vol #: 14
2007D-0249 Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
C 6 OSMA Vol #: 1
2007E-0440 Patent Term Extension Application for SYMBICORT Inhalation Aerosol (formoterol fumarate dihydrate and budesonide), U.S. Patent No. 5,674,860
APP 1 AstraZeneca AB Vol #: 1
LET 1 U.S. Patent and Trademark Office to FDA/CDER Vol #: 1
2007M-0380 P070009 - REALIZE Adjustable Gastric Band
AAV 1 Ethicon EndoSurgery, Inc. Vol #: 1
2007M-0408 P000009/S004 - Tachos DR Atrial Tx Implantable Cardioverter Defibrillator (ICD) System
AAV 1 Biotronik Inc. Vol #: 1
2007M-0409 P060005 - IMMULITE/IMMULITE 1000 Free PSA Assay and IMMULITE/IMMULITE 2000 Free PSA Assay
AAV 1 Siemens Medical Solutions Diagnostics Vol #: 1
2007M-0410 P060038 - Mitroflow Aortic Pericardial Heart Valve
AAV 1 CarboMedics Inc. Vol #: 1
2007M-0411 P070012 - Exponent Self-Expanding Carotid Stent System with Over-the-Wire or Rapid-Exchange Delivery System
AAV 1 Medtronic Vascular Vol #: 1
2007M-0413 P060017 - GeneSearch Breast Lymph Node (BLN) Assay
AAV 1 Veridex, LLC Vol #: 1
2007M-0415 Humanitarian Device Exemption Approval for Epicel cultured epidermal autograft (CEA) H990002 by Genzyme Biosurgery
AAV 1 Genzyme Biosurgery Vol #: 1
2007N-0277 Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
TS 1 D. Balentine Vol #: 2
TS 2 R. Black Vol #: 2
TS 3 S. Borra Vol #: 2
TS 4 C. Boville Vol #: 2
TS 5 C. Clark Vol #: 2
TS 6 T. Dean Vol #: 2
TS 7 C. Epstein Vol #: 2
TS 8 H. Falco Vol #: 2
TS 9 V. Fulgoni Vol #: 2
TS 10 N. Green Vol #: 2
TS 11 M. Hager Vol #: 2
TS 12 C. Harriman Vol #: 2
TS 13 R. Hildwind Vol #: 2
TS 14 M. Jacobson Vol #: 2
TS 15 D. Katz Vol #: 2
TS 16 A. M. Krautheim Vol #: 2
TS 17 M. L. Abbe Vol #: 2
TS 18 B. Mitchell Vol #: 3
TS 19 M. Ordman Vol #: 3
TS 20 T. Parinyasiri Vol #: 3
TS 21 E. Pivonka Vol #: 3
TS 22 M. Rayner Vol #: 3
TS 23 J. Ritter Vol #: 3
TS 24 R. M. Robertson Vol #: 3
TS 25 B. Schneeman Vol #: 3
TS 26 P. Thompson Vol #: 3
TS 27 J. Willen Van denBrink Vol #: 3
TS 28 S. Weiss Vol #: 3
TS 29 K. Wiemer Vol #: 3
TS 30 J.Wills Vol #: 3
TS 31 M. K. Young Vol #: 3
2007P-0235 Change the labeling requirements for eggs sold in the United States
C 255 S. Keller Vol #: 4
C 256 P. Griffiths Vol #: 4
C 257 J. Sancis Vol #: 4
C 258 C. Cavins Vol #: 4
2007V-0441 GCP-2C (V-2) Variance Application for Night Vision System
ACK 1 FDA/DDM to Night Vision System - A DRS Technologies Company Vol #: 1
VAR 1 Night Vision System - A DRS Technologies Company Vol #: 1

Page created on November 8, 2007 ue

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