Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Basic Information
- Device Name
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
- Trade Name
- NATRELLE SILICONE-FILLED BREAST IMPLANT
- PMA Number
- P020056
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- FTR
- Generic Name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Regulation Number
- 878.3540
- Medical Specialty
- General, Plastic Surgery
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 17, 2007
- Date Received
- February 26, 2007
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A TRADE NAME CHANGE FROM INAMED SILICONE-FILLED BREAST IMPLANTS TO NATRELLE SILICONE-FILLED BREAST IMPLANTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NATRELLE SILICONE-FILLED BREAST IMPLANTS AND IS INDICATED FOR BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD AND FOR BREAST RECONSTRUCTION FOR WOMEN OF ANY AGE. BREAST AUGMENTATION INCLUDES PRIMARY BREAST AUGMENTATION TO INCREASE THE BREAST SIZE, AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY. BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION TO REPLACE BREAST TISSUE THAT HAS BEEN REMOVED DUE TO CANCER OR TRAUMA OR THAT HAS FAILED TO DEVELOP PROPERLY DUE TO A SEVERE BREAST ABNORMALITY. BREAST RECONSTRUCTION ALSO INCLUDES REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST RECONSTRUCTION SURGERY.
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 |
|---|---|---|---|
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | FDA class 3 | General, Plastic Surgery |