Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
• Classification Name: device, thermal ablation, endometrial
• Generic Name: thermal ballo0n endometrial ablation system
• Applicant: ETHICON WOMEN'S HEALTH & UROLOGY
• PMA Number: P970021
• Supplement Number: S026
• Date Received: 03/06/2009
• Decision Date: 04/28/2009
• Product Code: MNB [ Registered Establishments with MNB ]
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: real-time process
• Supplement Reason: labeling change - minor
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for revised patient labeling.