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: NovaSure Impedance Controlled Endometrial Ablation System
• Generic Name: Device, thermal ablation, endometrial
• Applicant: Hologic, Inc.; 250 Campus Dr.; Malborough, MA 01752
• PMA Number: P010013
• Supplement Number: S085
• Date Received: 10/04/2021
• Decision Date: 01/04/2022
• Product Code: MNB
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for a revision to the NovaSure post approval study protocol, S0112003.