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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 CYROABLATION THERAPY SYSTEM
Classification Namedevice, thermal ablation, endometrial
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP000032
Supplement NumberS013
Date Received08/24/2005
Decision Date07/03/2006
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: 1) updates to the software, i. E. , in-ice detection; 2) improvement in the locking tabs; and 3) labeling changes.
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