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Sientra OPUS Silicone Gel Breast Implants

by Tiger Aesthetics Medical, LLC

PMA P070004

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 P070004↗

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 NumberP070004 Date9 Mar 2012ApprovedStatusActive

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  • Withdrawn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

Trade Name
Sientra Silicone Gel Breast Implants
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 Sientra Opus Silicone Gel Breast Implants are Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled, designed for breast augmentation and reconstruction. These devices are intended for women aged 22 and older, including primary augmentation and revision procedures to correct or enhance prior surgeries. They are also used for primary breast reconstruction following tissue removal due to cancer, trauma, or congenital abnormalities, as well as revision reconstruction to refine outcomes.

These implants are supplied sterile and intended for single-use. They are classified as Class III medical devices under FDA regulations and are approved via PMA (Premarket Approval). Available in various sizes and projections, they are intended for use in sterile surgical settings by qualified plastic surgeons. No MRI safety classifications or reusable indications are specified in the regulatory data.

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