|
Device | SCULPTRA |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P030050 |
Supplement Number | S006 |
Date Received | 10/09/2009 |
Decision Date | 12/02/2009 |
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 REVISION OF THE SCULPTRA PHYSICIAN AND PATIENT LABELING. |
Post-Approval Study | Show Report Schedule and Study Progress |