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: NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
• Classification Name: device, thermal ablation, endometrial
• Generic Name: thermal endometrial ablation device
• Applicant: CYTYC CORP.
• PMA Number: P010013
• Supplement Number: S008
• Date Received: 07/27/2004
• Decision Date: 08/13/2004
• Product Code: MNB [ Registered Establishments with MNB ]
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: real-time process
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for modifications to the rf controller, model 09.