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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 NumberS025
Date Received02/06/2008
Decision Date07/16/2008
Withdrawal Date09/07/2023
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE TRANSFER OF THE DEWAR ASSEMBLY COMPONENT PROCUREMENT, INCOMING RECEIVING AND INSPECTION, AND SUB-ASSEMBLY ACTIVITIES, INCLUDING MACHINE GRIND AND NITROGEN TESTING, FROM AMERICAN MEDICAL SYSTEMS TO JOINING TECHNOLOGIES.
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