RESTYLANE L AND PERLANE L INJECTABLE GEL
FDA premarket approval P040024/S065 · decided 2013-02-28
Approval details
- PMA number
- P040024
- Supplement
- S065
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RESTYLANE L AND PERLANE L INJECTABLE GEL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2012-12-04
- Decision date
- 2013-02-28
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR A CHANGE TO THE PLUNGER ROD FOR THE 2.25 ML SYRINGE FOR RESTYLANE L AND PERLANE L INJECTABLE GEL (2 ML FILL SIZES).
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