SIENTRA SILICONE GEL BREAST IMPLANTS

FDA premarket approval P070004 · decided 2012-03-09

Approval details

PMA number

P070004

Trade name

SIENTRA SILICONE GEL BREAST IMPLANTS

Generic name

Prosthesis, breast, noninflatable, internal, silicone gel-filled

Applicant

Tiger Aesthetics Medical, LLC

Date received

2007-01-22

Decision date

2012-03-09

Days to decision

1873 days

Decision code

APPR

Product code

FTR

Advisory committee

General, Plastic Surgery

Expedited review

No

Location

Franklin, WI

Statement

APPROVAL FOR THE SIENTRA SILICONE GEL BREAST IMPLANTS. THIS DEVICE IS INDICATED FOR: 1) BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD. BREAST AUGMENTATION INCLUDES PRIMARY BREAST AUGMENTATION AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF PRIMARY BREAST AUGMENTATION SURGERY; AND 2) BREAST RECONSTRUCTION. 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