PMA P990075S068

Device: MENTOR Saline-Filled and Spectrum™ Breast Implants
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S068
Product code: FWM
Decision date: 2026-05-12
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: to add SSP Simatrix Supplier (Lubrizol) to manufacture, sterilize, and package Mentor Packaged Fill Tubes for the MENTOR Saline-Filled Breast Implants.

Current openFDA PMA Record#

Device: MENTOR Saline-Filled and Spectrum™ Breast Implants
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S068
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2026-05-12
Decision code: OK30
Date received: 2026-04-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to add SSP Simatrix Supplier (Lubrizol) to manufacture, sterilize, and package Mentor Packaged Fill Tubes for the MENTOR Saline-Filled Breast Implants.