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Mentor MemoryShape Breast Implants

by Mentor Worldwide, LLC

PMA P060028

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P060028↗

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 NumberP060028 Date14 Jun 2013ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
PMA Number
FDA Product Code
FTR
Device Class
Class III
Regulation
21 CFR Part 878.3540
Advisory Committee
General, Plastic Surgery
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

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

Mentor MemoryShape Breast Implants are silicone gel-filled, noninflatable internal breast prostheses. They are indicated for breast augmentation in women at least 22 years old, including primary augmentation and revision surgery, as well as breast reconstruction following cancer, trauma, or developmental abnormalities, including revision surgery.

These implants are supplied sterile and intended for single-use implantation. They are regulated as Class III devices under FDA PMA approval (P060028) and are used in general and plastic surgery settings. Storage and handling should follow manufacturer guidelines to maintain sterility and integrity prior to use.

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Questions

AI-generated answers, 18 Sep 2026

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

  • What is the intended use of Mentor MemoryShape Breast Implants?

    The device is indicated for breast augmentation in females aged 22 years or older, including primary augmentation to increase breast size and revision surgery to correct or improve prior results. It is also indicated for breast reconstruction, including primary reconstruction after cancer, trauma, or developmental failure, and revision surgery to improve prior reconstruction outcomes.

  • Are Mentor MemoryShape Breast Implants reusable or single-use?

    Mentor MemoryShape Breast Implants are supplied sterile and intended for single-use implantation only. Reuse is not permitted, as it could compromise sterility, device integrity, and patient safety.

  • What regulatory authorization do Mentor MemoryShape Breast Implants have?

    These implants have received FDA Premarket Approval (PMA) under number P060028, which was approved on June 14, 2013. They are classified as Class III devices under regulation number 878.3540.