RESTYLANE, RESTYLANE-L,PERLANE,PERLANE-L,RESTYLANE SILK
FDA premarket approval P040024/S073 · decided 2015-07-01
Approval details
- PMA number
- P040024
- Supplement
- S073
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RESTYLANE, RESTYLANE-L,PERLANE,PERLANE-L,RESTYLANE SILK
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2014-05-01
- Decision date
- 2015-07-01
- Days to decision
- 426 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR RESTYLANE LYFT WITH LIDOCAINE. THIS DEVICE IS INDICATED FOR IMPLANTATION INTO THE DEEP DERMIS TO SUPERFICIAL SUBCUTIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL FOLDS AND WRINKLES, SUCH AS NASOLABIAL FOLDS; AND FOR SUBCUTANEOUS TO SUPRAPERIOSTEAL IMPLANTATION FOR CHEEK AUGMENTATION AND CORRECTION OF AGE-RELATED MIDFACE CONTOUR DEFICIENCIES IN PATIENTS OVER THE AGE OF 21.
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