|
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 | S052 |
Date Received | 01/28/2011 |
Decision Date | 07/18/2011 |
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 |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR AN EXTENSION TO THE EXPIRATION DATE OF THE LIDOCAINE HYDROCHLORIDE RAW MATERIAL FROM 12 MONTHS TO 24 MONTHS. |
Approval Order | Approval Order |