|
Device | SEPRAFILM ADHESION BARRIER |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S031 |
Date Received | 06/09/2008 |
Decision Date | 06/20/2008 |
Product Code |
MCN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF VISUAL REPRESENTATIONS OF THE DIRECTIONS FOR USE SECTION OF THE CURRENT APPROVED PACKAGE INSERT. |