|
Device | APLIGRAF |
Generic Name | Dressing, wound and burn, interactive |
Applicant | ORGANOGENESIS, INC. 150 DAN RD. CANTON, MA 02021 |
PMA Number | P950032 |
Supplement Number | S070 |
Date Received | 12/13/2012 |
Decision Date | 03/10/2014 |
Conversion Date
|
08/14/2013 |
Product Code |
MGR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF AN ALTERNATE SOURCE OF A CRITICAL MATERIAL USED IN THE MANUFACTURE OF APLIGRAF. |