Restylane Refyne, Restylane Defyne, and Restylane Kysse
FDA premarket approval P140029/S034 · decided 2020-11-06
Approval details
- PMA number
- P140029
- Supplement
- S034
- 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
- 2020-10-07
- Decision date
- 2020-11-06
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Changes to the distribution systems for Water for Injection (WFI) and changes to producer and distribution system of compressed air in Line 1 (L1) at Q-Med ABUppsala used for the manufacture of Restylane Refyne, Restylane Defyne, and Restylane Kysse.
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