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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.
 
DeviceNOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namedevice, thermal ablation, endometrial
Applicant
HOLOGIC, INC.
250 campus drive
marlborough, MA 01752
PMA NumberP010013
Supplement NumberS014
Date Received05/12/2005
Decision Date07/22/2005
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
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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