# P990075: Mentor Corporation Saline-Filled and Spectrum (R) Mammary Prostheses

- Pathway: PMA
- Applicant: Mentor Worldwide, LLC
- Decided: May 10, 2000 after 180 days
- Product code: FWM (Prosthesis, Breast, Inflatable, Internal, Saline)
- Device class: 3
- Regulation: 21 CFR 878.3530
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Sep 30, 2021 · Class II · Z-0367-2022: Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.
- Mar 27, 2017 · Class II · Z-2070-2017: Missing Dome Pack accessory.

Source page: https://510kreport.com/device/P990075
Methodology: https://510kreport.com/methodology