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: GENESYS HTA SYSTEM
• Generic Name: Device, thermal ablation, endometrial
• Applicant: Axora Medical, Inc.; 1 Independent Dr. Suite 2300; Jacksonville, FL 32202
• PMA Number: P000040
• Supplement Number: S022
• Date Received: 01/12/2012
• Decision Date: 02/14/2012
• 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  
ADDITION OF A NEW SUPPLIER IN THE MANUFACTURING PROCESS.