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NatrelleNatrelle 410 Highly Cohesive Silicone-Filled Breast Implants

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Natrelle is a Breast implant product (Class III device), registered by Allergan. Linked registrations: US P040046. First approved in US on 2013-02-20 (P040046). Data as of 2026-11-09.

  • Regulatory classBreast implant · Class III device
  • HolderAllergan
  • JurisdictionsUS
  • Updated2026-11-09 · v1

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

Registration and basics

Natrelle

Product
Regulatory class
Class III device
Category
Breast implant
US · FDA PMA
P040046
Name on registration
NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
Registrant
Allergan
First approval
2013-02-20
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

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Registration timeline

  1. US

    P040046 first approved

  2. US

    P040046 · P040046/S026

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Implement an Electronic Data Acquisition (EDA) System to collect cy…

  3. US

    P040046 · P040046/S027

    135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval to implement an additional incoming s…

  4. US

    P040046 · P040046/S029

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Replace paper chart recorders and to use an electric heating module…

  5. US

    P040046 · P040046/S030

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Implementing changes to the gel filling process, specifically, chan…

  6. US

    P040046 · P040046/S032

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Addition of an alternative detection method for the Quality Control…

  7. US

    P040046 · P040046/S031

    Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜Approval of the revised protocol for the post-approval study (PAS) protocol.

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
  • P040046: Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜Approval of the rev…2021-07-26
  • P040046: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Additio…2020-07-30
  • P040046: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Impleme…2019-06-27
  • P040046: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Replace…2018-08-01
  • P040046: 135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Pack…2018-06-27

Sources

1