|
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 | S002 |
Date Received | 11/18/1996 |
Decision Date | 12/17/1996 |
Product Code |
MCN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement NEW MANUFACTURING SITE LOCATED AT GENZYME FINE CHEMICAL, QUALITY CONTROL LABORATORY, ENGLAND |