Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels
FDA premarket approval P140029/S031 · decided 2020-12-04
Approval details
- PMA number
- P140029
- Supplement
- S031
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2020-09-14
- Decision date
- 2020-12-04
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval of changes to the Line 3 cleanrooms 9:169, 9:170, 9:177 and 9:190 in Facility 2, Building 9 at Q-Med ABs site located at Seminariegatan 21, SE-752 58 Uppsala, Sweden, used for the manufacturing of Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels.
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