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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceHER OPTION CRYOABLATION THERAPY SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namedevice, thermal ablation, endometrial
Applicant
CooperSurgical, Inc.
95 corporate dr.
trumbull, CT 06611
PMA NumberP000032
Supplement NumberS020
Date Received05/17/2006
Decision Date08/15/2006
Product Code
MNB[ Registered Establishments with 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 Product No
Approval Order Statement 
Approval for a change in adhesive formulation used to bond the thermocouple and heater wires for the device.
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