|
Device | PREVELLE SILK |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | GENZYME BIOSURGERY 55 CAMBRIDGE PARKWAY CAMBRIDGE, MA 02142 |
PMA Number | P030032 |
Supplement Number | S013 |
Date Received | 09/02/2011 |
Decision Date | 10/07/2011 |
Withdrawal Date
|
02/10/2016 |
Product Code |
LMH |
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 ADDITION OF A RAW MATERIAL IDENTIFICATION SYSTEM AND AN AUTOMATED FILTER INTEGRITY TEST INSTRUMENT. |