RESTYLANE INJECTABLE GEL
FDA premarket approval P040024/S061 · decided 2012-08-10
Approval details
- PMA number
- P040024
- Supplement
- S061
- 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
- 2012-07-10
- Decision date
- 2012-08-10
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- TRANSFER OF LABORATORY TESTING EQUIPMENT TO THE NEWLY CONSTRUCTED QUALITY CONTROL LABORATORY TESTING SITE WITHIN THE Q-MED FACILITY.
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