RESTYLANE INJECTABLE GEL
FDA premarket approval P040024/S021 · decided 2008-05-07
Approval details
- PMA number
- P040024
- Supplement
- S021
- 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
- 2008-04-07
- Decision date
- 2008-05-07
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- CHANGE IN STERILITY TESTING LABORATORY USED IN THE MANUFACTURING OF RESTYLANE INJECTABLE GEL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.