PMA P950034S015

Device: SEPRAFILM(TM) BIORESORBABLE MEMBRANE
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S015
Product code: MCN
Decision date: 2000-06-23
Generic name: Barrier, absorbable, adhesion
Approval order statement: THE ELIMINATION OF ANNUAL LOT STABILITY TESTING FOR SEPRAFILM(TM) BIORESORBABLE MEMBRANE (SEPRAFILM(TM)). THIS CHANGE WILL ELIMINATE THE ANNUAL LOT STABILITY TESTING REQUIREMENT, AND DECREASE THE QUANTITY OF THE PRODUCT USED FOR STABILITY LOT FAILURES DURING A TESTING PERIOD OF OVER THREE YEARS.

Current openFDA PMA Record#

Device: SEPRAFILM(TM) BIORESORBABLE MEMBRANE
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S015
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 2000-06-23
Decision code: OK30
Date received: 2000-05-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: THE ELIMINATION OF ANNUAL LOT STABILITY TESTING FOR SEPRAFILM(TM) BIORESORBABLE MEMBRANE (SEPRAFILM(TM)). THIS CHANGE WILL ELIMINATE THE ANNUAL LOT STABILITY TESTING REQUIREMENT, AND DECREASE THE QUANTITY OF THE PRODUCT USED FOR STABILITY LOT FAILURES DURING A TESTING PERIOD OF OVER THREE YEARS.