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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 CAPSURE SP NOVUS
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP850089
Supplement NumberS041
Date Received05/03/1999
Decision Date06/11/1999
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for labeling changes to the Technical Specification manuals for the CapSure(R) Z Novus Model 5554 and CapSure(R) SP Novus Model 5592 pacing leads.
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