SCULPTRA AESTHETIC
FDA premarket approval P030050/S014 · decided 2013-05-28
Approval details
- PMA number
- P030050
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SCULPTRA AESTHETIC
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2012-12-20
- Decision date
- 2013-05-28
- Days to decision
- 159 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR THE REVISION OF A PRECAUTION STATEMENT IN YOUR PRODUCT LABEL TO STATE: SCULPTRA AESTHETIC SHOULD ONLY BE USED BY A HEALTHCARE PRACTITIONER TRAINED TO CORRECT SHALLOW TO DEEP NASOLABIAL CONTOUR DEFICIENCIES AND OTHER FACIAL WRINKLES, IN WHICH DEEP DERMAL GRID PATTERN (CROSS-HATCH) INJECTION TECHNIQUE IS APPROPRIATE, AFTER THE HEALTHCARE PRACTITIONER IS FULLY FAMILIAR WITH THE PRODUCT, WAS, PRODUCT EDUCATIONAL MATERIALS, AND THE ENTIRE PACKAGE INSERT AND PATIENT LABELING. THE DEVICE,
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