Restylane Refyne, Restylane Defyne
FDA premarket approval P140029/S001 · decided 2017-04-12
Approval details
- PMA number
- P140029
- Supplement
- S001
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restylane Refyne, Restylane Defyne
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2017-01-11
- Decision date
- 2017-04-12
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for the addition of a second dialysis equipment to complement the current vessel used in the bulk manufacturing process for Restylane Refyne and Restylane Defyne.
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