|
Device | SCULPTRA AESTHETIC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P030050 |
Supplement Number | S002 |
Date Received | 07/28/2006 |
Decision Date | 07/28/2009 |
Product Code |
LMH |
Docket Number | 09M-0370 |
Notice Date | 08/04/2009 |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SCULPTRA AESTHETIC. THE DEVICE IS INDICATED FOR USE IN IMMUNE-COMPETENT PEOPLE AS A SINGLEREGIMEN FOR CORRECTION OF SHALLOW TO DEEP NASOLABIAL FOLD CONTOUR DEFICIENCIES AND OTHER FACIALWRINKLES IN WHICH DEEP DERMAL GRID PATTERN (CROSS-HATCH) INJECTION TECHNIQUE IS APPROPRIATE. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |