RESTYLANE INJECTABLE GEL
FDA premarket approval P040024/S023 · decided 2008-09-29
Approval details
- PMA number
- P040024
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RESTYLANE INJECTABLE GEL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2008-06-09
- Decision date
- 2008-09-29
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR A CHANGE IN PRODUCT LABELING THAT INCLUDED INFORMATION REGARDING INCREASED DURATION OF DEVICE EFFECTIVENESS.
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