RESTYLANE INJECTABLE GEL
FDA premarket approval P040024/S052 · decided 2011-07-18
Approval details
- PMA number
- P040024
- Supplement
- S052
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RESTYLANE INJECTABLE GEL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2011-01-28
- Decision date
- 2011-07-18
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR AN EXTENSION TO THE EXPIRATION DATE OF THE LIDOCAINE HYDROCHLORIDE RAW MATERIAL FROM 12 MONTHS TO 24 MONTHS.
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