Restylane Silk
FDA premarket approval P040024/S096 · decided 2017-10-11
Approval details
- PMA number
- P040024
- Supplement
- S096
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restylane Silk
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2017-02-16
- Decision date
- 2017-10-11
- Days to decision
- 237 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for use of a small bore, blunt tip cannula with Restylane Silk for submucosal implantation for lip augmentation in patients over the age of 21.
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