Restylane Refyne, Restylane Defyne and Restylane Kysse (injectable gels)
FDA premarket approval P140029/S033 · decided 2022-05-27
Approval details
- PMA number
- P140029
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restylane Refyne, Restylane Defyne and Restylane Kysse (injectable gels)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2020-09-28
- Decision date
- 2022-05-27
- Days to decision
- 606 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for (1) a new syringe and new plunger, new plunger rod, new finger grip, and new secondary packaging for products approved under PMA P140029; (2) implementation of these changes on a new manufacturing line (L3) for automated assembly and packaging; and (3) modification of the secondary packaging and labelling to fit the new syringe and packaging line.
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