RESTYLANE REFYNE and RESTYLANE DEFYNE
FDA premarket approval P140029/S015 · decided 2018-11-19
Approval details
- PMA number
- P140029
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTYLANE REFYNE and RESTYLANE DEFYNE
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2018-10-22
- Decision date
- 2018-11-19
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Change in the manufacturing procedure/introduction of an In-Process Control (IPC) used in the bulk process for Restylane Refyne and Restylane Defyne.
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