Restylane / Perlane / Restylane-L / Restylane-Lyft(formerly Perlane-L) Restylane Silk.
FDA premarket approval P040024/S100 · decided 2017-11-17
Approval details
- PMA number
- P040024
- Supplement
- S100
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restylane / Perlane / Restylane-L / Restylane-Lyft(formerly Perlane-L) Restylane Silk.
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2017-10-24
- Decision date
- 2017-11-17
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Change in the quality specification of Lidocaine Hydrochloride to align it with the updated USP monograph and the introduction of skip testing for some of the in-house tests already performed by the manufacturer of Lidocaine Hydrochloride.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.