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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceINTERTACH TM IMPLANTABLE PACEMAKER PULSE
Generic NamePULSE-GENERATOR, SINGLE CHAMBER, SINGLE
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP860007
Date Received03/03/1986
Decision Date12/31/1986
Withdrawal Date 07/19/2012
Product Code LWW 
Docket Number 87M-0031
Notice Date 03/11/1987
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S020 S021 S022 S023 S024 
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