Restylane Refyne, Restylane Defyne
FDA premarket approval P140029/S004 · decided 2018-01-31
Approval details
- PMA number
- P140029
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restylane Refyne, Restylane Defyne
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2017-06-14
- Decision date
- 2018-01-31
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for a manufacturing site located at Q-Med AB, Seminariegatan 31, SE-752 58 Uppsala, Sweden, for manufacturing and sterilization of Restylane Refyne and Restylane Defyne.
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