Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870  [E-mail] 

DOCKETS ENTERED on December 9, 1999

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]
 
97N-484S Human Cellular and Tissue-Based Products *
99P-5298 Request for an Exemption Performance Standard 21 CFR Part 898 *
99P-5317 ANDA for a Generic Version of Enalapril *
86F-0312 COMPONENTS OF PAPER & PAPERBOARD IN CONTACT WITH DRY FOOD

BKG 1 Background material Vol#: 1

NFR 1 HFS-215 Vol#: 1

97N-484S Human Cellular and Tissue-Based Products

C 7 Hugh Melnick MD Vol#: 6

C 8 Eye Bank Assoc of America Vol#: 6

C 9 NYU Medical Center Vol#: 6

C 10 Charles H Smith Vol#: 6

C 11 University of NC/Div of Repro&Endocrin Vol#: 6

C 12 Elizabeth V Simon Vol#: 6

C 13 Southwest Fertility Services Vol#: 6

C 14 Sofamor Danek Vol#: 6

C 15 The Collis Group Vol#: 6

C 16 Thomas T Lee MD Vol#: 6

C 17 John B Mazur MD Vol#: 6

C 18 Greater Pine Island Lions Club Vol#: 6

C 19 Shah N Siddiqi MD Vol#: 6

C 20 Louis J Levy Jr MD Vol#: 6

C 21 Martin Edwards MD Vol#: 6

C 22 Michigan Orthopaedic Center Vol#: 6

C 23 Orthopaedic Specialists of Nebraska Vol#: 6

C 24 Orlando Orthopaedic Vol#: 6

C 25 Orthopedic Assoc Vol#: 6

C 26 Neusurgical Group of Texas Vol#: 6

C 27 Susan A Messina Vol#: 6

C 28 Northwestern Neurological Assoc Vol#: 6

C 29 Britt M Borden MD Vol#: 6

C 30 Health Science Center/State Univ of NY Vol#: 6

C 31 Q Scout Vol#: 6

C 32 Atlanta Bone & Joint Surgeons Vol#: 6

EMC 1 Tim Stewart-Winter Vol#: 6

EMC 2 Will Mackintosh Vol#: 6

EMC 3 Sarah Kowalski Vol#: 6

EMC 4 Carl Stein Vol#: 6

99D-4809 Applications Covered by Section 505(b)(2)

GDL 1 Guidance Vol#: 1

NAD 1 HFD-560 Vol#: 1

99D-4910 Mammography Quality Standards Act Final Regulations #3

GDL 1 Guidance Vol#: 1

NAD 1 HFZ-215 Vol#: 1

99M-0150 Vocare Bladder System, H980005

N 1 HFZ-215 Vol#: 1

99M-0255 PMA Vocare Bladder System

N 1 HFZ-215 Vol#: 1

99M-0293 Visx Excimer Laser Systems Models B & C for PRK for High Myo

N 1 HFZ-215 Vol#: 1

99M-0870 PMA Urolume endoprosthesis for Detrusor Ext Sphincter Dyssyn

N 1 HFZ-215 Vol#: 1

99M-0871 PMA Cypress Bioscience, Prosorba Column

N 1 HFZ-215 Vol#: 1

99M-1073 PMA TransScan T-Scan 2000

N 1 HFZ-215 Vol#: 1

99M-1167 PMA Keravision Intacs, P980031

N 1 HFZ-215 Vol#: 1

99M-1306 PMA Medtronic Interstim System for Urinary Control

N 1 HFZ-215 Vol#: 1

99M-1520 PMA Thermo Cardiosystems Inc, HeartMate VE LVAS P920014/S7

N 1 HFZ-215 Vol#: 1

99M-1521 PMA Thoratec Ventricular Assist Device System, P870072/S5

N 1 HFZ-215 Vol#: 1

99M-1696 NIR ON Ranger w/SOX & NIR ON Ranger Premounted Stent Sys

N 1 HFZ-215 Vol#: 1

99M-1851 PMA Daig Livewire TC Steerable Electrophysiology Catheter

N 1 HFZ-215 Vol#: 1

99M-1980 P970061 - SCIMED RADIUS Coronary Stent with Delivery System

N 1 HFZ-215 Vol#: 1

99M-1981 P970024 - Angeion Sentinel Implantable Cardioverter Defibril

N 1 HFZ-215 Vol#: 1

99M-1982 P960006; SWEET TIP Rx Steroid-Eluting Positive-Fixation

N 1 HFZ-215 Vol#: 1

99M-2015 P980037 - AnjioJet Rheolytic Thrombectomy System

N 1 HFZ-215 Vol#: 1

99M-2016 P980003; Chilli Cooled Ablation System

N 1 HFZ-215 Vol#: 1

99M-2028 P980009 - Magic WALLSTENT Endoprosthesis

N 1 HFZ-215 Vol#: 1

99M-2143 PMA Home Access Hepatitis C Check & Hepatitis C Check Expres

N 1 HFZ-215 Vol#: 1

99M-2144 PMA, AutoCyte Prep System, P970018

N 1 HFZ-215 Vol#: 1

99M-2168 PMA Biex, Inc., Salest

N 1 HFZ-215 Vol#: 1

99M-2169 P980022; Continuous Glucose Monitoring System

N 1 HFZ-215 Vol#: 1

99M-2338 P970029; Eclipse TMR Holmium Laser System

N 1 HFZ-215 Vol#: 1

99M-2551 PMA TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesi

N 1 HFZ-215 Vol#: 1

99M-2605 PMA Novacor Left Ventricular Assist System

N 1 HFZ-215 Vol#: 1

99M-2606 PMA Guidant Pulsar & Pulsar Max Pulse Generators

N 1 HFZ-215 Vol#: 1

99M-2671 P980035 - Medtronic.Kappa 700/600 Pacemakers

N 1 HFZ-215 Vol#: 1

99M-2672 P950015 - The Heart Laser CO2 TMR System

N 1 HFZ-215 Vol#: 1

99M-2748 PMA Bayer Immuno 1 PSA Assay, P950021/S1

N 1 HFZ-215 Vol#: 1

99M-4134 H990004; CardioSEAL Septal Occlusion System

N 1 HFZ-215 Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

TR 1 Transcript 11/18/99 (Chicago) Vol#: 15

TS 2 Organic Indepents Vol#: 14

99P-5298 Request for an Exemption Performance Standard 21 CFR Part898

CP 1 Medtronic Neurological Vol#: 1

99P-5317 ANDA for a Generic Version of Enalapril

ACK 1 HFA-305 Vol#: 1

PSA 1 TorPharm, Division of Apotex Inc. Vol#: 1