|
Device | RESTYLANE/PERLANE/RESTYLANE-L/PERLANE-L INJECTABLE GELS |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S070 |
Date Received | 05/28/2013 |
Decision Date | 11/14/2014 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR NEW SUPPLIER OF RAW HYALURONIC ACID (I.E., HTL BIOTECHNOLOGYS.A.S., FRANCE). |