| |
| Device | NATRELLE SILICONE-FILLED BREAST IMPLANTS |
|---|
| Generic Name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
|---|
| Regulation Number | 878.3540 |
|---|
| Applicant | Allergan
2525 Dupont Dr.
Irvine, CA 92612 |
|---|
| PMA Number | P020056 |
|---|
| Supplement Number | S002 |
|---|
| Date Received | 02/23/2007 |
|---|
| Decision Date | 05/02/2007 |
|---|
| Product Code |
FTR |
| Advisory Committee |
General & Plastic Surgery |
|---|
| Supplement Type | Normal 180 Day Track |
|---|
| Supplement Reason | Change Design/Components/Specifications/Material |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Predetermined Change Control Plan Authorized | No |
|---|
| Recalls | CDRH Recalls |
|---|
Approval Order Statement
APPROVAL FOR THE DIPHENYL PATCH DESIGN. 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. |
| Post-Approval Study | Show Report Schedule and Study Progress |
|---|
