Restylane® Refyne, Restylane® Defyne, Restylane® Kysse, Restylane® Contour
FDA premarket approval P140029/S044 · decided 2021-12-09
Approval details
- PMA number
- P140029
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restylane® Refyne, Restylane® Defyne, Restylane® Kysse, Restylane® Contour
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2021-11-15
- Decision date
- 2021-12-09
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Addition of a new supplier for ready-to-use solutions used in the manufacturing of Restylane Refyne, Restylane Defyne, Restylane Kysse, and Restylane Contour
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