|
Device | HYLAFORM AND HYLAFORM PLUS |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | GENZYME BIOSURGERY 55 CAMBRIDGE PARKWAY CAMBRIDGE, MA 02142 |
PMA Number | P030032 |
Supplement Number | S004 |
Date Received | 09/23/2005 |
Decision Date | 11/02/2005 |
Withdrawal Date
|
02/10/2016 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN EXTENSION OF THE HYLAFORM AND HYLAFORM PLUS SHELF LIFE FROM 24 TO 36 MONTHS. |