RESTYLANE INJECTION GEL
FDA premarket approval P040024/S002 · decided 2006-01-19
Approval details
- PMA number
- P040024
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTYLANE INJECTION GEL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2005-06-24
- Decision date
- 2006-01-19
- Days to decision
- 209 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY IN UPPSALA, SWEDEN.
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