PMA P970021

Device: GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S044
Product code: MNB
Decision date: 2016-01-04
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL FOR CHANGES TO THE GYNECARE THERMACHOICE III UBT LABELS, INSTRUCTIONS FOR USE, OPERATING MANUAL, AND PATIENT LABELING.

Current openFDA PMA Record#

Device: GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S044
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2016-01-04
Decision code: APPR
Date received: 2015-10-06
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE GYNECARE THERMACHOICE III UBT LABELS, INSTRUCTIONS FOR USE, OPERATING MANUAL, AND PATIENT LABELING.