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Natrelle Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

FDA PMA

Class III (US FDA PMA)

PMA P040046

by Allergan

Identity

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

Identifiers

PMA Number
P040046 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

The Natrell Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants are a type of noninflatable, internal, silicone gel-filled breast prosthesis. They are designed for use in breast augmentation and reconstruction procedures. The implants are made of a highly cohesive silicone gel filling and are anatomically shaped to provide a natural look and feel. The implants are intended for women at least 22 years old for breast augmentation, and for breast reconstruction to replace breast tissue that has been removed due to cancer or trauma.

The Natrell 410 Highly Cohesive Silicone-Filled Breast Implants have been authorized by the FDA and are supplied in various sizes. They are designed for single-use and are not reusable. The implants are made by Allergan and are regulated by the FDA under the regulation number 878.3540. The device is classified as a Class 3 device and has been assigned the product code FTR.

Frequently asked questions

What are the Natrell 410 Highly Cohesive Silicone-Filled Breast Implants used for?

The Natrell 410 Highly Cohesive Silicone-Filled Breast Implants are used for breast augmentation and reconstruction in women. They are intended for women at least 22 years old for breast augmentation, and for breast reconstruction to replace breast tissue that has been removed due to cancer or trauma.

What is the material of the Natrell 410 Highly Cohesive Silicone-Filled Breast Implants?

The Natrell 410 Highly Cohesive Silicone-Filled Breast Implants are made of a highly cohesive silicone gel filling.

Are the Natrell 410 Highly Cohesive Silicone-Filled Breast Implants reusable?

No, the Natrell 410 Highly Cohesive Silicone-Filled Breast Implants are designed for single-use and are not reusable.

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. Sources consulted: Allergan Natrelle 410 Silicone-Filled Breast Implants ... - FDA, Natrelle® | Natrelle.com, Patient Decision-Making for Management of Style... - Lippincott, Natrelle 410 Extra-Full Projection Silicone Breast Implants - PMC, 4 Things You Need to Know About the Allergan Breast Implant ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Allergan

Sources (1)

  • FDA PMA P040046 24 fields · synced Sep 18, 2026