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Gynecare ThermaChoice III Uterine Balloon Therapy System

by Gynecare, Inc. PMA

Withdrawn United States

PMA P970021

Overview

The Gynecare ThermaChoice III Uterine Balloon Therapy System is a thermal endometrial ablation device designed for clinical use. It is indicated for the treatment of menorrhagia, or excessive uterine bleeding, resulting from benign causes.

This system is intended for use in premenopausal women who have completed childbearing. The device is regulated under FDA PMA authorization for its specific clinical application in obstetrics and gynecology.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

Withdrawn since 12 Dec 1997. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP970021 Date12 Dec 1997Approval withdrawnStatusWithdrawn

Coverage

1 jurisdiction

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

United States — FDA PMA Withdrawn

Recalls

1 recall · FDA

    • Terminated Z-0602-2016 FDA Class II initiated 3 Dec 2015 via P970021, on the same PMA

    Stability data does not substantiate the labeled two-year shelf life of affected product.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

PMA

Trade Name
Thermachoice Uterine Balloon Therapy(Ubt) System
Generic Name
Device, thermal ablation, endometrial
PMA Number
FDA Product Code
MNB
Device Class
Class III
Advisory Committee
Obstetrics/Gynecology
FDA Decision
APWD Approval withdrawn

Other devices from Gynecare, Inc.

Questions

  • What is the primary use of the ThermaChoice III Uterine Balloon Therapy System?

    The system is indicated for the treatment of menorrhagia, which is excessive uterine bleeding caused by benign conditions.

  • Who is the intended patient population for this device?

    This device is intended for premenopausal women who have completed childbearing and are experiencing excessive uterine bleeding due to benign causes.

  • Is this device approved for use?

    Yes, the system has received FDA PMA authorization for the treatment of menorrhagia in the specified patient population.