|
Device | SEPRAFILM ADHESION BARRIER |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S044 |
Date Received | 12/10/2015 |
Decision Date | 01/07/2016 |
Product Code |
MCN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITIONAL SUPPLIER OF POLY(METHYL METHACRYLATE) (PMMA), PLASKOLITE, TO BE QUALIFIED FOR USE IN THE MANUFACTURE OF THE CASTING SHEETS PRODUCED BY AIN PLASTICS. THE CASTING SHEETS ARE IN TURN USED IN THE MANUFACTURE OF THE DEVICE (SEPRAFILM). |