Restylane Refyne, Restylane Defyne and Restylane Kysse
FDA premarket approval P140029/S050 · decided 2023-11-09
Approval details
- PMA number
- P140029
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restylane Refyne, Restylane Defyne and Restylane Kysse
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2023-10-13
- Decision date
- 2023-11-09
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Changes to the distributor system for Water for Injection (WFI) used in manufacturing Restylane filler products
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