RESTYLANE INJECTABLE GEL
FDA premarket approval P040024/S105 · decided 2018-12-18
Approval details
- PMA number
- P040024
- Supplement
- S105
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTYLANE INJECTABLE GEL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2018-11-19
- Decision date
- 2018-12-18
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Extension of shelf-life for HA raw material used in the manufacturing of Restylane, Restylane-L, Perlane, Restylane Lyft with Lidocaine, and Restylane Silk.
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