|
Device | SEPRAFILM BIORESORBABLE MEMBRANE |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S016 |
Date Received | 05/30/2000 |
Decision Date | 07/07/2000 |
Product Code |
MCN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR ELIMINATION OF THE RAT CECAL ABRASION BIOASSAY AS A FINISHED PRODUCT RELEASE CRITERION AND AS A STABILITY TEST. |