RESTYLANE INJECTABLE GEL
FDA premarket approval P040024/S013 · decided 2007-10-12
Approval details
- PMA number
- P040024
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTYLANE INJECTABLE GEL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2007-09-14
- Decision date
- 2007-10-12
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- CHANGE TO THE METHOD FOR COUNTING SYRINGES DURING THE ASSEMBLY PROCESS FROM MANUAL TO AN AUTOMATED PROCESS.
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