SCULPTRA & SCULPTRA Aesthetic
FDA premarket approval P030050/S027 · decided 2017-12-14
Approval details
- PMA number
- P030050
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SCULPTRA & SCULPTRA Aesthetic
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2017-11-20
- Decision date
- 2017-12-14
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Installation of a new sieving process hopper for PLLA particles for Sculptra and Sculptra Aesthetic.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.