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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.
 
DeviceCAPSURE SP & CAPSURE Z
Generic NamePermanent defibrillator electrodes
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP850089
Supplement NumberS056
Date Received06/27/2007
Decision Date07/27/2007
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
CHANGE IN THE MOLDING VENDOR FOR THE IS-1 CONNECTOR SLEEVE COMPONENT FROM MEDTRONIC PUERTO RICO OPERATIONS COMPANY TO FMI, INC.
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