Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
• Generic Name: Device, thermal ablation, endometrial
• Applicant: Gynecare, Inc.; P.O. Box 151; Somerville, NJ 08876
• PMA Number: P970021
• Supplement Number: S044
• Date Received: 10/06/2015
• Decision Date: 01/04/2016
• Withdrawal Date: 10/25/2016
• Product Code: MNB
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: Real-Time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR CHANGES TO THE GYNECARE THERMACHOICE III UBT LABELS, INSTRUCTIONS FOR USE, OPERATING MANUAL, AND PATIENT LABELING.