PMA P990075S059

Device: Mentor® Saline-Filled and SPECTRUM® Breast Implants
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S059
Product code: FWM
Decision date: 2024-12-04
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: approval for a manufacturing change to the frequency of in-process cleaning steps for two primary packaging and assembly wash stations

Current openFDA PMA Record#

Device: Mentor® Saline-Filled and SPECTRUM® Breast Implants
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S059
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2024-12-04
Decision code: APPR
Date received: 2023-08-23
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing change to the frequency of in-process cleaning steps for two primary packaging and assembly wash stations