|
Device | SEPRAFILM BIORESORBABLE MEMBRANE |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S014 |
Date Received | 02/18/2000 |
Decision Date | 03/23/2000 |
Product Code |
MCN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the use of Denatured Alcohol 3C to precipitate the sodium hyaluronate/carboxymethylcellulose powder (HA/CMC) rather than ethyl alcohol. |