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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 OFFICE 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 NumberS028
Date Received06/06/2008
Decision Date03/27/2009
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the labeling the her option to include the results of the clinical study conducted to investigate the safety and effectiveness of the extended treatment regimen (etr).
Post-Approval StudyShow Report Schedule and Study Progress
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