|
Device | HYLAFORM FAMILY DERMAL FILLERS (HYLAFORM, HYLAFORM PLUS AND CAPTIQUE INJECTABLE GEL) |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | GENZYME BIOSURGERY 55 CAMBRIDGE PARKWAY CAMBRIDGE, MA 02142 |
PMA Number | P030032 |
Supplement Number | S008 |
Date Received | 04/15/2009 |
Decision Date | 02/24/2010 |
Withdrawal Date
|
02/10/2016 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING UPDATE TO CAPTIQUE AS A FOLLOW-UP TO THE POST-APPROVAL STUDY. |