|
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 | S015 |
Date Received | 03/04/2013 |
Decision Date | 08/15/2013 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REQUALIFICATION OF THE CONTRACT STERILIZER OF RECORD; ADDITION OF AN ALTERNATIVE STERILIZATION SITE, AND REPLACEMENT OF THE GAMMA RADIATION SOURCE FOR THE STERILITY EQUIPMENT. |