Medcxy

Product dossierBuilt from registrations, label text and platform-curated data

MentorMentor MemoryShape Breast Implants

Ask about this product

Mentor is a Breast implant product (Class III device), registered by Mentor Worldwide, LLC. Linked registrations: US P060028. First approved in US on 2013-06-14 (P060028). Data as of 2026-11-09.

  • Regulatory classBreast implant · Class III device
  • HolderMentor Worldwide, LLC
  • JurisdictionsUS
  • Updated2026-11-09 · v1

Registration and basics are public; findings and prices need an account

Registration and basics

Mentor

Product
Regulatory class
Class III device
Category
Breast implant
US · FDA PMA
P060028
Name on registration
MENTOR MEMORYSHAPE BREAST IMPLANTS
Registrant
Mentor Worldwide, LLC
First approval
2013-06-14
Checked against official page
Not yet checked field by field against the live official page

Public: fields from the registration record.

Label facts by jurisdiction

What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A

No data yet

Registration timeline

  1. US

    P060028 first approved

  2. US

    P060028 · P060028/S055

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Requalification of dry heat sterilization parameters/methods was su…

  3. US

    P060028 · P060028/S057

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Qualification of additional dry heat sterilization parameters/metho…

  4. US

    P060028 · P060028/S059

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜To seek approval of proposed changes to the incoming testing for ra…

  5. US

    P060028 · P060028/S060

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜To seek approval of updating quarterly quality control EndoSafe End…

  6. US

    P060028 · P060028/S058

    Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜For introduction of an Overall Compliance Rate in addition to the existing FDA-…

  7. US

    P060028 · P060028/S063

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜the addition of small size packaging tooling on the existing packag…

First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record. Dates on non-Chinese registrations keep the source's wording: UK devices show the registration date (MHRA does not approve them), Australia the ARTG start date, FDA devices the decision date.

Cross findings · Price observations

Sign in to see findings and prices

Findings and prices stay out of indexable pages.

Sign in to view

Recent changes

5
  • P060028: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜the add…2026-10-23
  • P060028: Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜For introduction of…2026-07-21
  • P060028: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜To seek…2026-02-04
  • P060028: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜To seek…2026-01-02
  • P060028: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Qualifi…2025-12-17

Sources

1