SCULPTRA AESTHETIC
FDA premarket approval P030050/S015 · decided 2013-08-15
Approval details
- PMA number
- P030050
- Supplement
- S015
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SCULPTRA AESTHETIC
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2013-03-04
- Decision date
- 2013-08-15
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR REQUALIFICATION OF THE CONTRACT STERILIZER OF RECORD; ADDITION OF AN ALTERNATIVE STERILIZATION SITE, AND REPLACEMENT OF THE GAMMA RADIATION SOURCE FOR THE STERILITY EQUIPMENT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.