Restylane Refyne, Restylane Defyne Injectable Gels
FDA premarket approval P140029/S025 · decided 2020-05-21
Approval details
- PMA number
- P140029
- Supplement
- S025
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Restylane Refyne, Restylane Defyne Injectable Gels
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2020-04-21
- Decision date
- 2020-05-21
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for revisions to the clinician and patient labeling of Restylane Defyne and Restylane Refyne to include updated safety information based upon post marketing surveillance data.
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