Mentor MemoryShape Breast Implants

FDA premarket approval P060028/S020 · decided 2017-04-04

Approval details

PMA number

P060028

Supplement

S020

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Mentor MemoryShape Breast Implants

Generic name

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

Applicant

Mentor Worldwide, LLC

Date received

2017-03-08

Decision date

2017-04-04

Days to decision

27 days

Decision code

OK30

Product code

FTR

Advisory committee

General, Plastic Surgery

Expedited review

No

Location

Irvin, CA

Statement

Addition of Vinatoru equipment for seal strength testing of packaging components that are used for Mentor Saline-Filled and SPECTRUM® Breast Implants, MemoryGel® Silicone Gel-Filled Breast Implants and MemoryShapeTM Breast Implants and their accessories.

510(k) clearances by this applicant