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: HTA SYSTEM
• Classification Name: device, thermal ablation, endometrial
• Applicant: BOSTON SCIENTIFIC CORP.
• PMA Number: P000040
• Supplement Number: S019
• Date Received: 09/06/2011
• Decision Date: 10/03/2011
• Product Code: MNB [ Registered Establishments with MNB ]
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Addition of a new manufacturing fixture and the modifications of an existing manufacturing fixture.