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: catheter, balloon, transcervical
• Generic Name: thermal ballo0n endometrial ablation
• Applicant: GYNECARE
• PMA Number: P970021
• Supplement Number: S011
• Date Received: 07/07/2004
• Decision Date: 08/23/2004
• Product Code: MKN [ Registered Establishments with MKN ]
• 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 labeling changes for the thermachoice iii.