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 Hyper links are part of the Docket title - not all dockets/documents are linked NOTE: Documents received by the Dockets Management Branch "MAY" be posted on the Internet. PLEASE DO NOT include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence. |
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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
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