|
Device | SEPRAFILM(TM) BIORESORBABLE MEMBRANE |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S015 |
Date Received | 05/24/2000 |
Decision Date | 06/23/2000 |
Product Code |
MCN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |