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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.
Classification Namedevice, thermal ablation, endometrial
PMA NumberP000040
Supplement NumberS013
Date Received02/13/2009
Decision Date05/14/2009
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 modifications to the hta procedure sheath (a component of the hta system) which include the addition of the cervical seal assist component and a redesign of the reservoir tip. The sheath, as modified, will be marketed under the trade name hta procerva procedure sheath.