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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 NumberS003
Date Received04/24/2003
Decision Date08/08/2003
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for early termination of the clinical technique standardization post-approval study.
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