RESTYLANE INJECTABLE GELS
FDA premarket approval P040024/S115 · decided 2019-09-30
Approval details
- PMA number
- P040024
- Supplement
- S115
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RESTYLANE INJECTABLE GELS
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2019-07-02
- Decision date
- 2019-09-30
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for the removal of testing of heavy metals in raw materials as per USP<231> and replacing it by a risk analysis on the final product based on ICH Q3D guideline for Elemental Impurities for Restylane Injectable Gels
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