|
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 | S018 |
Date Received | 07/22/2013 |
Decision Date | 08/16/2013 |
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 THE FOLLOWING CHANGES: 1) REPLACEMENT OF THE GAMMA RADIATION SOURCE AND REQUALIFICATION OF STERILIZATION AT THE DAGNEUX FRANCE FACILITY; 2) PACKAGING MODIFICATION FOR THE RAW MATERIAL, INCLUDING A NEW BAG SUPPLIER AND THE INTRODUCTION OF A NEW BAGGING CONFIGURATION; AND 3) REPLACEMENT OF THE GAMMA RADIATION SOURCE AND REQUALIFICATION AT THE SABLÉ FRANCE FACILITY. |
Post-Approval Study | Show Report Schedule and Study Progress |