|
Device | RESTYLANE, PERLANE, RESTYLANE L, PERLANE L, RESTYLANE SILK INJECTABLE GELS |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S076 |
Date Received | 07/02/2014 |
Decision Date | 12/08/2014 |
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 THE PROPOSED INTRODUCTION OF AN ALTERNATE BULK MANUFACTURING ROOMIN THE MANUFACTURING PROCESS USED IN FACTORY 2 (F2) AT THE QMED FACILITY IN UPPSALA, SWEDEN. |