|
Device | RESTYLANE L AND 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 | S039 |
Date Received | 04/16/2009 |
Decision Date | 01/29/2010 |
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 THE ADDITION OF 0.3% LIDOCAINE INTO RESTYLANE AND PERLANE. THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RESTYLANE-L AND PERLANE-L AND ISINDICATED FOR MID-TO-DEEP DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS; AND FOR IMPLANTATION INTO THE DEEP DERMIS TOSUPERFICIAL SUBCUTIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL FOLDS AND WRINKLES, SUCH ASNASOLABIAL FOLDS, RESPECTIVELY. |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |