RESTYLANE SILK SPHAL
FDA premarket approval P040024/S072 · decided 2014-06-13
Approval details
- PMA number
- P040024
- Supplement
- S072
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RESTYLANE SILK SPHAL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2013-10-21
- Decision date
- 2014-06-13
- Days to decision
- 235 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR RESTYLANE SILK. THIS DEVICE IS INDICATED FOR SUBMUCOSAL IMPLANTATION FOR LIP AUGMENTATION AND DERMAL IMPLANTATION FOR CORRECTION OF PERIORAL RHYTIDS IN PATIENTS OVER THE AGE OF 21.
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