Restylane Refyne, Restylane Defyne
FDA premarket approval P140029/S017 · decided 2019-08-13
Approval details
- PMA number
- P140029
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Restylane Refyne, Restylane Defyne
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2019-05-17
- Decision date
- 2019-08-13
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for reclassification of impurity C in lidocaine HCl.
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