SCULPTRA AND SCULPTRA AESTHETIC
FDA premarket approval P030050/S009 · decided 2011-12-09
Approval details
- PMA number
- P030050
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SCULPTRA AND SCULPTRA AESTHETIC
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2010-12-06
- Decision date
- 2011-12-09
- Days to decision
- 368 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR: 1) A REVISION OF SCULPTRA AND SCULPTRA AESTHETIC LABELING TO INCLUDE INFORMATION CONCERNING A PRECLINICAL IMAGING STUDY COMPLETED AS CONDITION OF APPROVAL; AND 2) TO REVISE THE STORAGE CONDITIONS PRESENTED IN YOUR PRODUCT LABEL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.