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Saline-Filled Mammary Prosthesis – Styles 5000, 5000PT, and Spectrum Post-Operatively Adjustable

by Mentor Worldwide, LLC

PMA P990075

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P990075↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP990075 Date10 May 2000ApprovedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0367-2022 FDA Class II initiated 30 Sep 2021

    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.

    • Terminated Z-2070-2017 FDA Class II initiated 27 Mar 2017

    Missing Dome Pack accessory.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Saline-Filled Mammary Prosthesis - Styles 5000 and 5000PT and Spectrum Post-Operatively Adjustable Saline-Filled Mammary
Trade Name
Mentor Corporation Saline-Filled and Spectrum (R) Mammary Prostheses
Generic Name
Prosthesis, breast, inflatable, internal, saline
PMA Number
FDA Product Code
FWM
Device Class
Class III
Regulation
21 CFR Part 878.3530
Advisory Committee
General, Plastic Surgery
FDA Decision
APPR Approved

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Prosthesis, Breast, Inflatable, Internal, Saline, classified under FDA device code FWM. It consists of saline-filled mammary implants designed for internal placement, offering adjustable volume post-surgery to refine aesthetic outcomes. The Spectrum series includes a removable fill tube, enabling intraoperative or postoperative adjustments. These implants are intended for use in reconstructive or cosmetic breast surgery procedures.

The prosthesis is supplied sterile and intended for single-use. It is approved under FDA_PMA (PMA number P990075) and falls under device class 3 regulations. Available in multiple sizes and styles (5000, 5000PT, and Spectrum), the device requires surgical implantation and may be adjusted up to six months postoperatively. Storage and handling must comply with sterile medical device protocols to ensure safety and efficacy.

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