|
Device | Seprafilm Adhesion Barrier |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S056 |
Date Received | 10/05/2023 |
Decision Date | 11/02/2023 |
Product Code |
MCN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval to add new information to the Warnings Section of the Seprafilm Adhesion Barrier ('Seprafilm') Instructions for Use. |