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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 NameMODELS 5342 & 5345 TEMPORARY PULSE GENERATORS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP820003
Supplement NumberS057
Date Received01/04/1991
Decision Date02/06/1991
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason change design/components/specifications - color additive
Expedited Review Granted? No
Combination Product No
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