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NatrelleNatrelle Saline-Filled Breast Implants

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Natrelle is a Breast implant product (Class III device), registered by Allergan. Linked registrations: US P040046, US P020056, US P990074. 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
US · FDA PMA
P020056
US · FDA PMA
P990074
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.Registrant and dates are from P040046; 3 registrations linked.

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

    P990074 first approved

  2. US

    P020056 first approved

  3. US

    P040046 first approved

  4. US

    P040046 · P040046/S026

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

  5. US

    P040046 · P040046/S027

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

  6. US

    P040046 · P040046/S029

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

  7. US

    P040046 · P040046/S030

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

  8. US

    P040046 · P040046/S032

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

  9. 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.

  10. US

    P990074 · P990074/S048

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Installation of a new patch curing oven and electronic data acquisi…

  11. US

    P990074 · P990074/S045

    Normal 180 Day Track｜Labeling Change - Indications/instructions/shelf life/tradename｜Approval for changes to the patient and physician label…

  12. US

    P990074 · P990074/S049

    135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval for a change to the annual re-validat…

  13. US

    P020056 · P020056/S059

    Real-Time Process｜Labeling Change - Indications/instructions/shelf life/tradename｜Approval for modifications to Physician and Patient Labeli…

  14. US

    P990074 · P990074/S050

    Real-Time Process｜Labeling Change - Indications/instructions/shelf life/tradename｜Approval for modifications to Physician and Patient Labeli…

  15. US

    P020056 · P020056/S061

    Normal 180 Day Track No User Fee｜Labeling Change - PAS｜Approval for including the final results from the BIFS-001 NBIR-Arm Clinical Study in…

  16. US

    P020056 · P020056/S063

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜The 30 Day notice is to notify FDA of the commissioning of the new …

  17. US

    P990074 · P990074/S053

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜The 30 Day notice is to notify FDA of the commissioning of the new …

  18. US

    P020056 · P020056/S050

    Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜acknowledgement of a submission that includes the BIFS-001: BIFS-arm Final Stud…

  19. US

    P020056 · P020056/S065

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜changes to the adhesive coating that is used to secure the lids to …

  20. US

    P990074 · P990074/S054

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜changes to the adhesive coating that is used to secure the lids to …

  21. US

    P020056 · P020056/S064

    Normal 180 Day Track No User Fee｜Labeling Change - PAS｜approval for revised labeling to include the results of the BIFS Arm study.

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
  • P020056: Normal 180 Day Track No User Fee｜Labeling Change - PAS｜approval for revised labe…2026-09-29
  • P020056: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜changes…2024-12-16
  • P990074: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜changes…2024-12-16
  • P020056: Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜acknowledgement of …2024-08-16
  • P990074: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜The 30 …2024-06-21

Sources

3