RESTYLANE/RESTYLANE-L/ PERLANE/ PERLANE-L , RESTYLANE SILK(INJECTABLE GELS)
FDA premarket approval P040024/S079 · decided 2016-01-26
Approval details
- PMA number
- P040024
- Supplement
- S079
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RESTYLANE/RESTYLANE-L/ PERLANE/ PERLANE-L , RESTYLANE SILK(INJECTABLE GELS)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2015-02-12
- Decision date
- 2016-01-26
- Days to decision
- 348 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR A NEW SYRINGE CONTAINER CLOSURE SYSTEM FOR RESTYLANE®, RESTYLANE-L®, PERLANE®, PERLANE-L® AND RESTYLANE® SILK.
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