RESTYLANE, RESTYLANE-L, PERLANE, RESTYLANE SILK, RESTYLANE LYFT, INJECTABLE GELS.
FDA premarket approval P040024/S086 · decided 2016-02-04
Approval details
- PMA number
- P040024
- Supplement
- S086
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTYLANE, RESTYLANE-L, PERLANE, RESTYLANE SILK, RESTYLANE LYFT, INJECTABLE GELS.
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2015-09-18
- Decision date
- 2016-02-04
- Days to decision
- 139 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for a change in control of the starting material (sodium hyaluronate).
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