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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 CRYOABLATION THERAPY SYSTEM
Classification Namedevice, thermal ablation, endometrial
ApplicantAMERICAN MEDICAL SYSTEMS GYNECOLOGY,INC
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 protocol or modification to a protocol
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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