SCULPTRA®
FDA premarket approval P030050/S044 · decided 2023-12-07
Approval details
- PMA number
- P030050
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SCULPTRA®
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2023-11-17
- Decision date
- 2023-12-07
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Addition of compounding reactors and new transfer lines between the new reactors for increasing manufacturing capacity.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.