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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 NameGENESYS HTA SYSTEM
Classification Namedevice, thermal ablation, endometrial
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP000040
Supplement NumberS014
Date Received05/06/2009
Decision Date04/23/2010
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ¿next generation¿ hta system with a redesigned operational unit (control unit, power cord, pedestal, iv pole) and a modified sterile procedure set. The device, as modified, will be marketed under the trade name genesys hta system and is indicated for ablation of the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
Post-Approval StudyShow Report Schedule and Study Progress
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