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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 UTERINE 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 NumberS030
Date Received11/23/2009
Decision Date01/20/2010
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the refrigerant blend used in the gas mix compressor (gmc) of the her option console.
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