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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceHER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantCooperSurgical, Inc.
95 Corporate Dr.
Trumbull, CT 06611
PMA NumberP000032
Supplement NumberS035
Date Received01/26/2010
Decision Date02/25/2010
Withdrawal Date 09/07/2023
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF A NEW MANUFACTURING PIECE OF EQUIPMENT TO ASSIST IN THE PRODUCTION PROCESS.
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