PMA P990075S065

Device: MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S065
Product code: FWM
Decision date: 2025-11-18
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: approval implementing packaging size updates for larger size Saline-Filled and SPECTRUM Breast Implants devices.

Current openFDA PMA Record#

Device: MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S065
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2025-11-18
Decision code: APPR
Date received: 2025-09-25
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval implementing packaging size updates for larger size Saline-Filled and SPECTRUM Breast Implants devices.