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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 CRYOABLATION THERAPY SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantCooperSurgical, Inc.
95 Corporate Dr.
Trumbull, CT 06611
PMA NumberP000032
Supplement NumberS017
Date Received01/17/2006
Decision Date02/16/2006
Withdrawal Date 09/07/2023
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE QUALITY TESTS USED TO EVALUATE THE THERMOCOUPLE WIRING IN THE DISPOSABLE CONTROL UNIT (DCU) AND FOR A CHANGE TO THE LABELING TO INCLUDE ADDITIONAL PRECAUTIONS/INSTRUCTIONS FOR THE YEAR.
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