Restylane® Contour
FDA premarket approval P140029/S032 · decided 2021-06-28
Approval details
- PMA number
- P140029
- Supplement
- S032
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Restylane® Contour
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2020-09-18
- Decision date
- 2021-06-28
- Days to decision
- 283 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Restylane Contour is indicated for use in cheek augmentation and correction of midface contour deficiencies in patients over the age of 21.
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