Medcxy

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

SientraSientra Silicone Gel Breast Implants

Ask about this product

Sientra is a Breast implant product (Class III device), registered by Tiger Aesthetics Medical, LLC. Linked registrations: US P070004. First approved in US on 2012-03-09 (P070004). Data as of 2026-11-09.

  • Regulatory classBreast implant · Class III device
  • HolderTiger Aesthetics Medical, LLC
  • JurisdictionsUS
  • Updated2026-11-09 · v1

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

Registration and basics

Sientra

Product
Regulatory class
Class III device
Category
Breast implant
US · FDA PMA
P070004
Name on registration
SIENTRA SILICONE GEL BREAST IMPLANTS
Registrant
Tiger Aesthetics Medical, LLC
First approval
2012-03-09
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

    P070004 first approved

  2. US

    P070004 · P070004/S043

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Sientra provided FDA with a detailed description and supporting doc…

  3. US

    P070004 · P070004/S046

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Sientra provided FDA with a detailed description and supporting doc…

  4. US

    P070004 · P070004/S044

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜a change to the surfactant used in the adhesive formulation of the …

  5. US

    P070004 · P070004/S047

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Risk assessment for raw material processing change (i.e. filter cha…

  6. US

    P070004 · P070004/S045

    135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜approval for a change to the releasing agent f…

  7. US

    P070004 · P070004/S048

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Provided information regarding the changes is sufficient.

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
  • P070004: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Provide…2026-04-22
  • P070004: 135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Pack…2025-11-20
  • P070004: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Risk as…2025-07-24
  • P070004: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜a chang…2024-08-21
  • P070004: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Sientra…2024-08-15

Sources

1