Implant, Dermal, For Aesthetic Use
Basic Information
- Device Name
- Implant, Dermal, For Aesthetic Use
- Trade Name
- SCULPTRA AESTHETIC
- PMA Number
- P030050
- Supplement Number
- S014
- Device Class
- FDA Class 3
- Product Code
- LMH
- Generic Name
- Implant, dermal, for aesthetic use
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 28, 2013
- Date Received
- December 20, 2012
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee 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, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SCULPTRA AESTHETIC AND IS INDICATED FOR USE IN IMMUNE-COMPETENT PEOPLE AS A SINGLE REGIMEN FOR CORRECTION OF SHALLOW TO DEEP NASOLABIAL FOLD CONTOUR DEFICIENCIES AND OTHER FACIAL WRINKLES IN WHICH DEEP DERMAL GRID PATTERN (CROSS-HATCH) INJECTION TECHNIQUE IS APPROPRIATE.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LMH | Implant, Dermal, For Aesthetic Use | FDA class 3 | Unknown |