RESTYLANE/PERLANE/RESTYLANE-L/PERLANE-L INJECTABLE GELS
FDA premarket approval P040024/S070 · decided 2014-11-14
Approval details
- PMA number
- P040024
- Supplement
- S070
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RESTYLANE/PERLANE/RESTYLANE-L/PERLANE-L INJECTABLE GELS
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2013-05-28
- Decision date
- 2014-11-14
- Days to decision
- 535 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR NEW SUPPLIER OF RAW HYALURONIC ACID (I.E., HTL BIOTECHNOLOGYS.A.S., FRANCE).
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