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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 | S051 |
Date Received | 12/01/2010 |
Decision Date | 10/11/2011 |
Product Code |
LMH |
Docket Number | 11M-0735 |
Notice Date | 10/20/2011 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT00935272
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR RESTYLANE INJECTABLE GEL. THIS DEVICE IS INDICATED FOR: 1) MID-TO-DEEP DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS; AND 2) SUBMUCOSAL IMPLANTATION FOR LIP AUGMENTATION IN PATIENTS OVER THE AGE OF 21. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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