|
Device | RESTYLANE INJECTABLE GEL |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S053 |
Date Received | 07/07/2011 |
Decision Date | 01/26/2012 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A RELOCATION OF THE CURRENT QUALITY CONTROL LABORATORY (QC-LAB) FOR CHEMICAL, MICROBIOLOGICAL AND RECEIVING INSPECTION ANALYSIS TO A NEW LOCATION WITH Q-MED¿S EXISTING FACILITIES. |