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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 NameCYBERLITH IV UNIPOLAR PULSE GENERATOR
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepacemaker, cardiac, programable
ApplicantBOSTON SCIENTIFIC
PMA NumberP800019
Date Received04/21/1980
Decision Date03/06/1981
Withdrawal Date 07/19/2012
Product Code
LWP[ Registered Establishments with LWP ]
Notice Date 06/09/1981
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S012 S013 
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