|
Device | APLIGRAF |
Generic Name | Dressing, wound and burn, interactive |
Applicant | ORGANOGENESIS, INC. 150 DAN RD. CANTON, MA 02021 |
PMA Number | P950032 |
Supplement Number | S059 |
Date Received | 07/01/2010 |
Decision Date | 02/14/2011 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO USE A RAPID MICROBIAL METHOD, AS AN ALTERNATE STERILITY TESTING METHOD FOR ALL IN-PROCESS LIQUID SAMPLES CURRENTLY TESTED PER UNITED STATES PHARMACOPEIA <71>, STERILITY TESTS. |