|
Device | Seprafilm Adhesion Barrier |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S053 |
Date Received | 05/11/2021 |
Decision Date | 06/09/2021 |
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 Establishment of clean hold times for new equipment used in the manufacturing process of Seprafilm Adhesion Barrier. |