MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT

FDA premarket approval P990075/S029 · decided 2014-11-26

Approval details

PMA number

P990075

Supplement

S029

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT

Generic name

Prosthesis, breast, inflatable, internal, saline

Applicant

Mentor Worldwide, LLC

Date received

2014-10-27

Decision date

2014-11-26

Days to decision

30 days

Decision code

APPR

Product code

FWM

Advisory committee

General, Plastic Surgery

Expedited review

No

Location

Irvin, CA

Statement

APPROVAL FOR MODIFICATIONS TO THE WINGED INFUSION SET ACCESSORY OF THE MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT. THE MODIFICATIONS INCLUDED: 1. TEXTURE, BEVELED EDGES, AND A FINGER HOLE WAS ADDED TO EACH (2) SIDE OF THE WING DESIGN; 2. PHTHALATE WAS ELIMINATED FROM THE WING MATERIAL: PVC NAKAN FEM 828 N N WITH DEHP WITH COLORANT MASTERBATCH PVC 9154 GREEN TO PVC NAKAN FEM 828 N N WITH DEHT WITH COLORANT MASTERBATCH PVC 9154 GREEN; AND3. PHTHALATE WAS ELIMINATED FROM THE TUBING MATERIAL:

510(k) clearances by this applicant