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 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: S035
• Date Received: 04/08/2011
• Decision Date: 05/05/2011
• Withdrawal Date: 10/25/2016
• Product Code: MNB
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
CHANGE IN RAW MATERIAL AND SUPPLIER.