|
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 | S023 |
Date Received | 06/09/2008 |
Decision Date | 09/29/2008 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN PRODUCT LABELING THAT INCLUDED INFORMATION REGARDING INCREASED DURATION OF DEVICE EFFECTIVENESS. |