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: HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
• Generic Name: Device, thermal ablation, endometrial
• Applicant: CooperSurgical, Inc.; 95 Corporate Dr.; Trumbull, CT 06611
• PMA Number: P000032
• Supplement Number: S038
• Date Received: 08/23/2012
• Decision Date: 02/06/2013
• Withdrawal Date: 09/07/2023
• Product Code: MNB
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR CHANGES TO THE LABELING TO REFLECT THE RESULTS OF THE POST-APPROVAL STUDY.