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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 NumberS006
Date Received07/18/2005
Decision Date09/21/2005
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the tenaculum stabilizer component to the hta procedure set and for changes to the packaging, shelf-life and labeling associated with the addition of the component.
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