|
Device | SEPRAFILM BIORESORBABLE MEMBRANE |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S006 |
Date Received | 06/02/1997 |
Decision Date | 06/30/1997 |
Product Code |
MCN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A 24 MONTH EXPIRATION DATE FOR SEPRAFILM BIORESORBABLE MEMBRANE. |