Thermachoice Uterine Balloon Therapy(Ubt) System

FDA premarket approval P970021 · Device, thermal ablation, endometrial

PMA numberP970021

Approval

Applicant
Gynecare, Inc.
Received
June 17, 1997
Decision date
December 12, 1997 (APWD)
Supplements
42, latest January 4, 2016
Product code
MNB – Device, Thermal Ablation, Endometrial

Official FDA PMA record

Approval order statement

Approval for the ThermaChoice(TM) Uterine Balloon Therapy(TM) UBT System. This device is indicated for the treatment of menorrhagia (excessive uterine bleeding) due to benign causes in premenopausal women for whom child bearing is complete.