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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.
 
Trade NameHER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
Classification Namedevice, thermal ablation, endometrial
ApplicantCOOPERSURGICAL, INC.
PMA NumberP000032
Supplement NumberS038
Date Received08/23/2012
Decision Date02/06/2013
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the labeling to reflect the results of the post-approval study.
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