|
Device | PREVELLE SILK & HYLAN B GEL |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | GENZYME BIOSURGERY 55 CAMBRIDGE PARKWAY CAMBRIDGE, MA 02142 |
PMA Number | P030032 |
Supplement Number | S009 |
Date Received | 09/11/2009 |
Decision Date | 10/09/2009 |
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 CHANGE IN SOLUTION SAMPLING AND A CHANGE IN SILK BULK PRODUCTION. |
Post-Approval Study | Show Report Schedule and Study Progress |