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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.
 
DeviceCYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER
Generic NamePULSE-GENERATOR, SINGLE CHAMBER, SINGLE
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP820022
Date Received04/07/1982
Decision Date11/07/1984
Withdrawal Date 07/20/2012
Product Code LWW 
Docket Number 84M-0386
Notice Date 12/12/1984
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S004 S005 
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