Restylane® Contour
FDA premarket approval P140029/S051 · decided 2024-07-17
Approval details
- PMA number
- P140029
- Supplement
- S051
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Restylane® Contour
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2024-01-17
- Decision date
- 2024-07-17
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for (1) a new plastic syringe and new plunger, new plunger rod, new finger grip, and new secondary packaging for Restylane Contour approved under PMA P140029; (2) implementation of these changes on a new manufacturing line (L3) for automated assembly and packaging; and (3) modification of the secondary packaging and labelling to fit the new syringe and packaging line.
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