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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 IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal endometrial ablation device
ApplicantCYTYC CORP.
PMA NumberP010013
Supplement NumberS014
Date Received05/16/2005
Decision Date07/22/2005
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the device performance protocol used to establish the shelf life of the novasure impedance controlled endometrial ablation system. The protocol used to assess package integrity, i. E. , ppq-012, previously approved is unchanged. ).
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