|
Device | SEPRAFILM ADHESION BARRIER/SEPRAFILM PROCEDURE PACK |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S025 |
Date Received | 04/30/2003 |
Decision Date | 05/28/2003 |
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 |
Approval Order Statement MANUFACTURING PROCESS CHANGE TO EXTEND THE ENDOTOXIN SPECIFICATION LIMIT OF HYALURONIC ACID (HA) RAW MATERIAL FROM <=0.04 EU/MG TO <=0.08 EU/MG. |