MENTOR MEMORYSHAPE BREAST IMPLANTS

FDA premarket approval P060028 · decided 2013-06-14

Approval details

PMA number

P060028

Trade name

MENTOR MEMORYSHAPE BREAST IMPLANTS

Generic name

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

Applicant

Mentor Worldwide, LLC

Date received

2006-10-02

Decision date

2013-06-14

Days to decision

2447 days

Decision code

APPR

Product code

FTR

Advisory committee

General, Plastic Surgery

Expedited review

No

Location

Irvin, CA

Statement

APPROVAL FOR THEMEMORYSHAPE BREAST IMPLANTS. THIS DEVICE IS INDICATED FOR FEMALES FOR THE FOLLOWING USES(PROCEDURES):1) BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD. BREAST AUGMENTATION INCLUDES PRIMARYBREAST AUGMENTATION TO INCREASE THE BREAST SIZE, AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY. 2) BREAST RECONSTRUCTION. BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION TO REPLACEBREAST TISSUE THAT HAS BEEN REMOVED DUE TO CANCER

510(k) clearances by this applicant