|
Device | SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S052 |
Date Received | 03/05/2021 |
Decision Date | 04/01/2021 |
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 Change to the clean hold time of a vessel used in the manufacturing process of Seprafilm Adhesion Barrier. |