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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 NameNOVASURE GLOBAL IMPENDENCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal endometrial ablation device
ApplicantCYTYC CORP.
PMA NumberP010013
Supplement NumberS012
Date Received10/25/2004
Decision Date03/24/2005
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at cytyc surgical products, heredia, costa rica.
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