RESTYLANE L AND PERLANE L INJECTABLE GELS
FDA premarket approval P040024/S039 · decided 2010-01-29
Approval details
- PMA number
- P040024
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RESTYLANE L AND PERLANE L INJECTABLE GELS
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2009-04-16
- Decision date
- 2010-01-29
- Days to decision
- 288 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- 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.
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