Restylane Injectable Gels
FDA premarket approval P040024/S102 · decided 2018-08-02
Approval details
- PMA number
- P040024
- Supplement
- S102
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restylane Injectable Gels
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2018-07-06
- Decision date
- 2018-08-02
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Change in supplier for the "puck press" used in manufacturing of Restylane Injectable Gels (Restylane, Restylane-L,Perlane, Restylane Lyft with Lidocaine, and Restylane Silk).
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