|
Device | SCULPTRA & 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 | S020 |
Date Received | 01/22/2014 |
Decision Date | 02/19/2014 |
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 REPLACEMENT OF THE RADIATION SOURCE AND SUBSEQUENT REQUALIFICATION OF THE RADIATION PROCESS AT THE FIRM¿S CONTRACT STERILIZER FACILITY. |