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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
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
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 - component
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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