Restylane Refyne and Restylane Defyne Injectable Gels
FDA premarket approval P140029/S023 · decided 2020-02-20
Approval details
- PMA number
- P140029
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restylane Refyne and Restylane Defyne Injectable Gels
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2020-01-21
- Decision date
- 2020-02-20
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Change from single batch dialysis to dual-batch dialysis in manufacturing.
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