RESTYLANE® Injectable Gels
FDA premarket approval P040024/S134 · decided 2022-09-30
Approval details
- PMA number
- P040024
- Supplement
- S134
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTYLANE® Injectable Gels
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2022-09-07
- Decision date
- 2022-09-30
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Add a permanent transverse wall between cleanrooms 9:175 and 9:176 in manufacturing L3 for Restylane®, Restylane®-L, Restylane® Lyft with Lidocaine, Perlane® and Restylane® Silk production.
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