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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, INC.
PMA NumberP000032
Supplement NumberS017
Date Received01/17/2006
Decision Date02/16/2006
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the quality tests used to evaluate the thermocouple wiring in the disposable control unit (dcu) and for a change to the labeling to include additional precautions/instructions for the year.
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