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Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants

by Motiva USA, LLC

PMA P230005

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P230005↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP230005 Date26 Sep 2024ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas
Generic Name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
PMA Number
FDA Product Code
FTR
Device Class
Class III
Regulation
21 CFR Part 878.3540
Advisory Committee
General, Plastic Surgery
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Motiva SmoothSilk Round Ergonomix breast implant is a noninflatable, internal prosthesis filled with silicone gel, indicated for breast augmentation. It is intended for women aged 22 years and older, including primary augmentation to increase breast size and revision surgery to correct or improve prior augmentation results.

Supplied by Motiva USA, LLC, this device is classified as a Class III medical device under FDA regulation 878.3540 and holds FDA Premarket Approval (PMA) number P230005. It is sterile, single-use, and intended for implantation in a surgical setting by qualified healthcare professionals.

Other devices from Motiva USA, LLC

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Motiva SmoothSilk Round Ergonomix breast implant?

    The Motiva SmoothSilk Round Ergonomix breast implant is indicated for breast augmentation in women aged 22 years and older. This includes primary breast augmentation to increase breast size and revision surgery to correct or improve the outcome of a prior primary breast augmentation procedure.

  • Who manufactures the Motiva SmoothSilk Round Ergonomix breast implant and what regulatory authorization does it have?

    The device is manufactured by Motiva USA, LLC and has received FDA Premarket Approval (PMA) under application number P230005, as indicated in the device data.

  • Is the Motiva SmoothSilk Round Ergonomix breast implant reusable or single-use?

    The Motiva SmoothSilk Round Ergonomix breast implant is a sterile, single-use device intended for implantation during surgery and is not designed for reuse.