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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 supplement. The device description may have changed. Be sure to look at the original PMA 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
ApplicantINTERMEDICS, INC.
PMA NumberP800019
Supplement NumberS001
Date Received04/24/1981
Decision Date06/12/1981
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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