|
Device | RESTYLANE SILK SPHAL |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S072 |
Date Received | 10/21/2013 |
Decision Date | 06/13/2014 |
Product Code |
LMH |
Docket Number | 14M-0872 |
Notice Date | 06/30/2014 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT01591369
|
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR RESTYLANE SILK. THIS DEVICE IS INDICATED FOR SUBMUCOSAL IMPLANTATION FOR LIP AUGMENTATION AND DERMAL IMPLANTATION FOR CORRECTION OF PERIORAL RHYTIDS IN PATIENTS OVER THE AGE OF 21. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |