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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 NameHYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
Classification Namedevice, thermal ablation, endometrial
ApplicantBOSTON SCIENTIFIC CORP.
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 - component
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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