|
Device | HYLAFORM (HYLAN B GEL), HYLAFORM PLUS, CAPTIQUE |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | GENZYME BIOSURGERY 55 CAMBRIDGE PARKWAY CAMBRIDGE, MA 02142 |
PMA Number | P030032 |
Supplement Number | S005 |
Date Received | 01/27/2006 |
Decision Date | 02/28/2006 |
Withdrawal Date
|
02/10/2016 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF A CLARIFICATION OF THE DEFINITION OF SERIOUS ADVERSE EVENTS. |