RESTYLANE
FDA premarket approval P020023/S012 · decided 2005-10-21
Approval details
- PMA number
- P020023
- Supplement
- S012
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTYLANE
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2005-06-06
- Decision date
- 2005-10-21
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR PERFORMING THE PROTEIN TESTING IN-HOUSE AT THE Q-MED QUALITY CONTROL LABORATORY AND TO CHANGE THE TEST METHOD SO AS TO ALLOW FOR THE DETECTION OF LOWER AMOUNTS OF PROTEIN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RESTYLANE AND IS INDICATED AS AN INJECTABLE GEL FOR AESTHETIC USE.
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