|
Device | SEPRAFILM ADHESION BARRIER |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S021 |
Date Received | 03/01/2002 |
Decision Date | 03/26/2002 |
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 MANUFACTURING CHANGE TO REPLACE THE CURRENT MANUAL CLEANING PROCESS FOR REMOVING RESIDUAL MANUFACTURING MATERIALS FROM EQUIPMENT WITH A SEMI-AUTOMATIC SUBSTRATE WASHER. THE SEMI-AUTOMATIC SUBSTRATE WASHER WOULD DECREASE THE TIME AND LABOR USED IN THE MANUFACTURING CLEANING PROCESS. |