|
Device | SCULPTRA AND SCULPTRA AESTHETIC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P030050 |
Supplement Number | S009 |
Date Received | 12/06/2010 |
Decision Date | 12/09/2011 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR: 1) A REVISION OF SCULPTRA AND SCULPTRA AESTHETIC LABELING TO INCLUDE INFORMATION CONCERNING A PRECLINICAL IMAGING STUDY COMPLETED AS CONDITION OF APPROVAL; AND 2) TO REVISE THE STORAGE CONDITIONS PRESENTED IN YOUR PRODUCT LABEL. |