|
Device | SEPRAFILM ADHESION BARRIER |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S028 |
Date Received | 11/18/2005 |
Decision Date | 12/05/2005 |
Product Code |
MCN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN PERFORMANCE SPECIFICATIONS TO ELIMINATE ETHANOL AND ISOPROPYL ALCOHOL TESTING FROM SEPRAFILM QUALITY CONTROL RELEASE CRITERIA. |