PMA P990075S066

Device: MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S066
Product code: FWM
Decision date: 2025-12-17
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: Qualification of additional dry heat sterilization parameters/methods as well as the bioburden/biological indicator validation approach were sufficient.

Current openFDA PMA Record#

Device: MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S066
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2025-12-17
Decision code: OK30
Date received: 2025-10-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of additional dry heat sterilization parameters/methods as well as the bioburden/biological indicator validation approach were sufficient.