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 Us]

DOCKETS ENTERED on May 22, 2002

TABLE OF CONTENTS

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96N-0277 Eligibility Criteria for Considering Additional Condition *
01N-0067 Reclassification of Dental Mercury *
01N-0322 Institutional Review Boards *
01N-0548 Guidelines for Voluntary Nutrition Labeling of Raw Fruits *
02N-0115 Risk Management of Prescription Drugs; Public Hearing *
02N-0169 Combination Products Containing Live Cellular Components *

96N-0277 Eligibility Criteria for Considering Additional Condition

EXT 1 Merck KGaA & U.S. EM Industries, Inc. Vol#: 3

99N-5556 Food Contact Substance Notification System

BKG 2 BACKGOUND MATERIAL Vol#: 1

NFR 1 Vol#: 1

REF 1 OMB Review Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 3493 Mary Amundson Vol#: 212

C 3494 Gretel Munroe Vol#: 212

00D-1360 Food-Contact Substance Notification System

GDL 2 GUIDELINE Vol#: 1

NAD 2 Vol#: 1

00E-1344 Patent Extension Comtan, No. 5,446,194

N 1 Vol#: 1

01M-0439 PMA Deflux Injectable Gel, P000029

NAD 1 Vol#: 1

01M-0451 P990038; DiaSorin ETI-MAK-2 PLUS ASSAY

NAD 1 Vol#: 1

01M-0452 P990041; DiaSorin ETI-AB-EBK PLUS ASSAY

NAD 1 Vol#: 1

01M-0453 P990042; DiaSorin ETI-AB-AUK PLUS ASSAY

NAD 1 Vol#: 1

01M-0454 P990043; DiaSorin ETI-EBK PLUS ASSAY

NAD 1 Vol#: 1

01M-0455 P990044; DiaSorin ETI-CORE-IGMK PLUS ASSAY

NAD 1 Vol#: 1

01M-0456 P990045; DiaSorin ETI-AB-COREK PLUS ASSAY

NAD 1 Vol#: 1

01M-0460 P000020; Stinger Ablation Catheter & Templink Extension Cabl

NAD 1 Vol#: 1

01M-0461 P830045/S076; Integrity Afx DR Model 5346 Dual Chamber Pulse

NAD 1 Vol#: 1

01M-0462 P880086/S083; Integrity Afx DR Model 5346 Dual Chamber Pulse

NAD 1 Vol#: 1

01M-0478 P990050 Optical Biopsy System

NAD 1 Vol#: 1

01M-0479 Focus Night & Day (Lotrafilcon A) Soft Contact Lenses

NAD 1 Vol#: 1

01M-0480 Focus Night & Day (Lotrafilcon A) Soft Contact Lenses P00030

NAD 1 Vol#: 1

01M-0482 OP-1 Implant, H010002

NAD 1 Vol#: 1

01M-0490 P980008/S005; LSX Excimer Laser System for Laser-Assisted

NAD 1 Vol#: 1

01M-0498 P000036; DERMAGRAFT

NAD 1 Vol#: 1

01M-0507 P990012; Elecsys HBsAg Immunassay, Elecsys HBsAg Confirmator

NAD 1 Vol#: 1

01M-0508 P000052; GALILEO Intravascular Radiotherapy System

NAD 1 Vol#: 1

01M-0509 P010017; SenoScan Full Field Digital Mammography System

NAD 1 Vol#: 1

01M-0520 P890057/S014; High Frequency Oscillatory Ventilator

NAD 1 Vol#: 1

01M-0522 PMA VISX Star Excimer Laser System, Models S2 & S3 P930016/S

NAD 1 Vol#: 1

01M-0523 GYNECARE INTERGEL Adhesion Prevention Solution, P990015

NAD 1 Vol#: 1

01M-0530 P000057; Ascension MCP

NAD 1 Vol#: 1

01M-0531 P980006/S004; PureVision Visibility Tinted Contact Lens

NAD 1 Vol#: 1

01M-0534 P010032; Genesis Neurostimulation (IPG) System

NAD 1 Vol#: 1

01M-0535 P930027/S004; Immulite PSA, Third Generation PSA, 2000, etc

NAD 1 Vol#: 1

01M-0536 P010021; Vitros Immunodiagnostic Products Anti-HCV etc.

NAD 1 Vol#: 1

01M-0537 P010007; Immulite AFP and Immulit 2000 AFP

NAD 1 Vol#: 1

01M-0567 P010003; BioGlue Surgical Adhesive

NAD 1 Vol#: 1

01M-0578 P000040; Hydro ThermAblator Endometrial Ablation System

NAD 1 Vol#: 1

01M-0579 P000053; AMS Sphincter 800 Urinary Prosthesis

NAD 1 Vol#: 1

01M-0581 P010020; AMS Acticon Neosphincter

NAD 1 Vol#: 1

01N-0067 Reclassification of Dental Mercury

C 5 American Dental Assn Vol#: 1

C 6 Andrew Hall Cutler, PhD Vol#: 1

01N-0234 Food Contact Substance Notification System

BKG 1 BACKGROUND MATERIAL Vol#: 1

NPR 1 Vol#: 1

01N-0322 Institutional Review Boards

C 8 Fox Chase Cancer Center Vol#: 1

01N-0548 Guidelines for Voluntary Nutrition Labeling of Raw Fruits

C 1 Ketchum Vol#: 1

02D-0199 Advertisements for High-Intensity Mercury Vapor discharge

BKG 1 BACKGOUND MATERIAL Vol#: 1

N 1 Vol#: 1

02D-0200 Sunlamp products performance standard and UVA tanning

N 1 Vol#: 1

02N-0077 Emergency Medical Device Shortage Program Survey

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1

02N-0115 Risk Management of Prescription Drugs; Public Hearing

LST 1 Agenda of May 22, 2002 meeting Vol#: 1

02N-0169 Combination Products Containing Live Cellular Components

APE 1 Boston Scientific Corporation Vol#: 2

02V-0238 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Long Island Laser Works Vol#: 1

02V-0239

ACK 1 HFA-305 Vol#: 1

VAR 1 Spellbound Productions Vol#: 1

02V-0240

ACK 1 HFA-305 Vol#: 1

VAR 1 Lazerus Laser Systems Vol#: 1