SCULPTRA
FDA premarket approval P030050/S003 · decided 2008-08-13
Approval details
- PMA number
- P030050
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- SCULPTRA
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2008-03-11
- Decision date
- 2008-08-13
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.