|
Device | SCULPTRA, SCULPTRA AESTHETIC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P030050 |
Supplement Number | S013 |
Date Received | 12/18/2012 |
Decision Date | 01/16/2013 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement DOES NOT QUALIFY AS A SUPP. - CHANGES SUBMITTED IN NEXT ANNUAL REPORT. |