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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameHYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM
Classification Namedevice, thermal ablation, endometrial
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP000040
Date Received09/25/2000
Decision Date04/20/2001
Product Code
MNB[ Registered Establishments with MNB ]
Docket Number 01M-0578
Notice Date 12/21/2001
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the hydro thermablator(r) endometrial ablation system. The device is intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom child bearing is complete.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 
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