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MentorMentor Saline-Filled Breast Implants

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Mentor is a Breast implant product (Class III device), registered by Mentor Worldwide, LLC. Linked registrations: US P990075. First approved in US on 2000-05-10 (P990075). 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
P990075
Name on registration
MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES
Registrant
Mentor Worldwide, LLC
First approval
2000-05-10
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

    P990075 first approved

  2. US

    P990075 · P990075/S065

    135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜approval implementing packaging size updates f…

  3. US

    P990075 · P990075/S066

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

  4. US

    P990075 · P990075/S067

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

  5. US

    P990075 · P990075/S068

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜to add SSP Simatrix Supplier (Lubrizol) to manufacture, sterilize, …

  6. US

    P990075 · P990075/S070

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approved change from quarterly to annual B/F testing.

  7. US

    P990075 · P990075/S071

    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.

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Recent changes

5
  • P990075: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜the add…2026-10-23
  • P990075: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approve…2026-10-21
  • P990075: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜to add …2026-05-12
  • P990075: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜To seek…2026-02-04
  • P990075: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Qualifi…2025-12-17

Sources

1