|
Device | SCULPTRA (INJECTABLE POLY-L-LACTIC ACID) & SCULPTRA AESTHETIC (INJECTABLE POLY -L-LACTIC ACID) |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P030050 |
Supplement Number | S010 |
Date Received | 03/25/2011 |
Decision Date | 06/14/2011 |
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 CHANGE THE LOCATION OF THE DESIGN CONTROL CENTER FOR SCULPTRA AND SCULPTRA AETHETIC FROM SANOFI AVENTIS U.S. LLC TO ANAGNI ITALY. |
Post-Approval Study | Show Report Schedule and Study Progress |