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Natrelle Silicone-Filled Breast Implants

FDA PMA

Class III (US FDA PMA)

PMA P020056

by Allergan

Identity

Trade Name
NATRELLE SILICONE-FILLED BREAST IMPLANTS FDA PMA
Generic Name
Prosthesis, breast, noninflatable, internal, silicone gel-filled FDA PMA

Identifiers

PMA Number
P020056 FDA PMA
FDA Product Code
FTR FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 878.3540 FDA PMA
Regulation Number
878.3540 FDA PMA
Advisory Committee
General, Plastic Surgery FDA PMA
FDA Decision
APPR Approved FDA PMA

Natrelle Silicone-Filled Breast Implants are noninflatable, internal silicone gel-filled breast prostheses. These devices are indicated for breast augmentation in women at least 22 years old and for breast reconstruction in women of any age, including primary procedures and revision surgeries to correct or improve previous results.

These implants are used to increase breast size or to replace breast tissue removed due to cancer, trauma, or severe breast abnormalities. The device is authorized under FDA PMA P020056. Please consult a qualified plastic surgeon for information regarding surgical application and clinical suitability.

Frequently asked questions

Who is eligible for Natrelle breast augmentation?

According to the FDA approval, these implants are indicated for breast augmentation in women who are at least 22 years of age.

Can these implants be used for breast reconstruction?

Yes, these implants are indicated for breast reconstruction in women of any age to replace tissue lost due to cancer, trauma, or severe breast abnormalities, as well as for revision surgery.

What type of device are Natrelle breast implants?

They are classified as noninflatable, internal, silicone gel-filled breast prostheses, which are regulated under the product code FTR.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Allergan

Sources (1)

  • FDA PMA P020056 24 fields · synced Sep 18, 2026