Restylane Refyne, Restylane Defyne, Restylane Kysse
FDA premarket approval P140029/S040 · decided 2021-10-19
Approval details
- PMA number
- P140029
- Supplement
- S040
- 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
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2021-06-02
- Decision date
- 2021-10-19
- Days to decision
- 139 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for a new alternative bulk process on one manufacturing line to produce flexible batch sizes.
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