|
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 | S027 |
Date Received | 11/20/2017 |
Decision Date | 12/14/2017 |
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 Installation of a new sieving process hopper for PLLA particles for Sculptra and Sculptra Aesthetic. |