|
Device | SEPRAFILM ADHESION BARRIER AND SEPRAFILM PROCEDURE PACK |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S024 |
Date Received | 03/27/2003 |
Decision Date | 04/25/2003 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement MANUFACTURING CHANGE BY THE ADDITION OF AN ALTERNATE RAW MATERIAL SUPPLIER OF HYALURONIC ACID (HA). |