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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.
 
DeviceMODEL 5388 EXTERNAL PULSE GENERATOR
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 NumberS080
Date Received07/13/2007
Decision Date08/10/2007
Product Code LWP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MINOR MODIFICATION TO A COMPONENT INSPECTION PROCEDURE OCCURRING AT A FINISHED DEVICE CONTRACT MANUFACTURING SUPPLIER.
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