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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.
 
DeviceMODELS 5342 & 5345 TEMPORARY PULSE GENERATORS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP820003
Supplement NumberS057
Date Received01/04/1991
Decision Date02/06/1991
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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