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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHTA SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namedevice, thermal ablation, endometrial
Applicant
Boston Scientific Corp.
100 boston scientific way
mb 21
marlborough, MA 01752
PMA NumberP000040
Supplement NumberS012
Date Received09/25/2007
Decision Date11/02/2007
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE TO THE INTERFACE BETWEEN THE THERMISTOR CONDITIONING BOARD, MOTHER BOARD, AND TEMPERATURE CONTROLLER BOARD TO IMPROVE CONNECTIONS AND MITIGATE SIGNAL LOSS.
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