Table of Contents

PAV 1 HFZ-1 Vol#: 1

91P-0416 Recall of Hip & Knee Prosthetic Devices

PDN 1 HFZ-2 to Florence B Horowitz Vol#: 1

92P-0173 Declassify External Assembled Lower Limb Prosthesis

PAV 1 HFZ-2 Vol#: 1

SUP 1 American Orthotic and Prosthetic Assn. Vol#: 1

93P-0193 Extend exempt 23 low risk generic type dental devices

PAV 1 HFZ-2 Vol#: 2

94P-0001 Use/add Vapor-Pressure Powered Implantable Infusion Pumps

PDN 1 HFZ-2 Vol#: 1

95A-0074 Importation of Silicone Gel-Filled Breast Prostheses

APA 1 HFZ-2 Vol#: 1

95P-0077 Objectives Re: Enforcement of Medical Device Regulations

ANS 1 HFZ-1 Vol#: 1

95P-0140 Diagnostic Ultrasound Devices - Criteria for 510(k) and PMA

PDN 1 HFZ-1 Vol#: 1

95P-0152 Enforce SMDA & Existing Regs Re: Mfgs of dental lubricants

ANS 1 HFZ-2 Vol#: 1

95P-0214 Labeling for mammography bucky & Compression paddles

PAV 1 HFZ-2 Vol#: 1

96A-0141 Medical Devices Amendments Preempt State Law

ANS 1 HF-11 Vol#: 2

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

THESE LINKED COMMENTS DUPLICATE THOSE FOR 97P-0197 AND 98N-1230, ALSO BELOW

C 335 Shirley Sheffer Vol#: 13

C 336 Barbara L. & Randall G. Erdley Vol#: 13

C 337 Sarah Richter Vol#: 13

C 338 M. Liane Salgado Vol#: 13

C 339 Taralyn Di Simone Vol#: 13

C 340 Elsa Bowker Vol#: 13

C 341 Stephanie Baker Vol#: 13

C 342 Harold Schessler Vol#: 13

C 343 Tara K. Joyce Vol#: 13

C 344 Robert L. Bull Vol#: 13

C 345 Jean Chadwick Vol#: 13

C 346 James Pittard Vol#: 13

C 347 Beverly McLaughlin Vol#: 13

C 348 Mike McLean Vol#: 13

C 349 John L. Robinson Vol#: 13

C 350 Jim Dunn Vol#: 13

C 351 Stephanie Gipson Vol#: 13

C 352 C. A. Brameier, L. Ac. Vol#: 13

C 353 Kimberly Freeman Vol#: 13

C 354 Anndrija E. Long Vol#: 13

C 355 Susan Howshern Vol#: 13

C 356 Carole Bica Vol#: 13

C 357 Kel Lee Cannis Vol#: 13

C 358 Mary M. Horner, RN Vol#: 13

C 359 Linda Kelson Vol#: 13

C 360 Juliana Harrison Vol#: 13

C 361 Susan Shaw Vol#: 13

97A-0173 Advisory opinion on Labeling of Contact Lens Care Products

ANS 1 HFZ-1 to Bausch & Lomb Vol#: 1

97A-0534 Clarify duty of mfgr to provide info to users etc software

APA 1 HFZ-1 Vol#: 1

97P-0197 Require that warning labels about risks of salmonella enteri

C 336 Shirley Sheffer Vol#: 12

C 337 Barbara L. & Randall G. Erdley Vol#: 12

C 338 Sarah Richter Vol#: 12

C 339 M. Liane Salgado Vol#: 12

C 340 Taralyn Di Simone Vol#: 12

C 341 Elsa Bowker Vol#: 12

C 342 Stephanie Baker Vol#: 12

C 343 Harold Schessler Vol#: 12

C 344 Tara K. Joyce Vol#: 12

C 345 Robert L. Bull Vol#: 12

C 346 Jean Chadwick Vol#: 12

C 347 James Pittard Vol#: 12

C 348 Beverly McLaughlin Vol#: 12

C 349 Mike McLean Vol#: 12

C 350 John L. Robinson Vol#: 12

C 351 Jim Dunn Vol#: 12

C 352 Stephanie Gipson Vol#: 12

C 353 C. A. Brameier, L. Ac. Vol#: 12

C 354 Kimberly Freeman Vol#: 12

C 355 Anndrija E. Long Vol#: 12

C 356 Susan Howshern Vol#: 12

C 357 Carole Bica Vol#: 12

C 358 Kel Lee Cannis Vol#: 12

C 359 Mary M. Horner, RN Vol#: 12

C 360 Linda Kelson Vol#: 12

C 361 Juliana Harrison Vol#: 12

C 362 Susan Shaw Vol#: 12

98D-0362 Stability Testing of Drug Substances and Drug Products

MM 1 Minutes of 9/22/99 meeting Vol#: 5

98D-0834 Non-Contraceptive Estrogen Class Labeling

GDL 2 Guidance Vol#: 1

NAD 2 Guidance Vol#: 1

98D-0969 Effects of antimicrobial new animal drugs/use in food-produc

NM 1 Vol#: 1

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 335 Shirley Sheffer Vol#: 16

C 336 Barbara L. & Randall G. Erdley Vol#: 16

C 337 Sarah Richter Vol#: 16

C 338 M. Liane Salgado Vol#: 16

C 339 Taralyn Di Simone Vol#: 16

C 340 Elsa Bowker Vol#: 16

C 341 Stephanie Baker Vol#: 16

C 342 Harold Schessler Vol#: 16

C 343 Tara K. Joyce Vol#: 16

C 344 Robert L. Bull Vol#: 16

C 345 Jean Chadwick Vol#: 16

C 346 James Pittard Vol#: 16

C 347 Beverly McLaughlin Vol#: 16

C 348 Mike McLean Vol#: 16

C 349 John L. Robinson Vol#: 16

C 350 Jim Dunn Vol#: 16

C 351 Stephanie Gipson Vol#: 16

C 352 C. A. Brameier, L. Ac. Vol#: 16

C 353 Kimberly Freeman Vol#: 16

C 354 Anndrija E. Long Vol#: 16

C 355 Susan Howshern Vol#: 16

C 356 Carole Bica Vol#: 16

C 357 Kel Lee Cannis Vol#: 16

C 358 Mary M. Horner, RN Vol#: 16

C 359 Linda Kelson Vol#: 16

C 360 Juliana Harrison Vol#: 16

C 361 Susan Shaw Vol#: 16

98N-1265 Distribution of Compounded Drug Products

C 6114 Maryhee Rudersdort Vol#: 171

C 6115 No Signature Vol#: 171

C 6116 Liz Laubenstein Vol#: 171

C 6117 Florence E. Kendall Vol#: 171

C 6118 Dianne Goodwin Vol#: 171

C 6119 Dennis & Kathleen Langer Vol#: 171

98P-0145 Requirements for demonstrating In Vivo Bioequivalence

C 16 Form Letter Count 7 Vol#: 5

98P-0456 Performance Standard for Electrode Lead Wires Patient Cables

PAV 1 HFZ-1 Vol#: 1

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 681 Taura Watts Vol#: 18

C 682 Thomas Wade Vol#: 18

C 683 Bonnie L. Derwin Vol#: 18

99H-2990 Civil Money Penalty;Peters Fuel Corporation,dba Hancock Truc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2991 Civil Money Penalty;Sinclair Oil Corporation,dba Sinclair #2

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2992 Civil Money Penalty;Spiro Mellis,dba Dan Mellis Liquors

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2993

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2994 Civil Money Penalty;Steve Griffen & Craig Ferguson,dba Count

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2995 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart Store #

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99P-2630 Establish a Daily Value for "added sugars"

C 47 Form Letter Count 238 Vol#: 2