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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCYBERLITH IV UNIPOLAR PULSE GENERATOR
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP800019
Supplement NumberS009
Date Received06/20/1985
Decision Date08/29/1985
Withdrawal Date 07/19/2012
Product Code LWP 
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
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