Restylane® Kysse
FDA premarket approval P140029/S021 · decided 2020-03-26
Approval details
- PMA number
- P140029
- Supplement
- S021
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Restylane® Kysse
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2019-09-03
- Decision date
- 2020-03-26
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for Restylane Kysse. The device is intended for injection into the lips for lip augmentation and for correction of upper perioral rhytids in patients over the age of 21.
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