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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.
 
DeviceHYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION 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 NumberS008
Date Received05/15/2006
Decision Date06/23/2006
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 1) addition of the linear flash card memory to the central processing board; 2) temperature controller pid settings/increase in cycle time programmed into heater logic and controller board; and 3) addition of components to the level sensor board.
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