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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.
 
DeviceMEDTRONIC MICRO MINIX PULSE GENERATOR MODEL 8360
Generic NamePulse-generator, single chamber, sensor driven, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP850051
Supplement NumberS025
Date Received03/29/1990
Decision Date10/30/1990
Product Code LWO 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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