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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, CAPSURE SP, CAPSURE SP NOVUS, CAPSURE SENSE
Generic NamePermanent defibrillator electrodes
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP830061
Supplement NumberS041
Date Received03/24/2008
Decision Date04/18/2008
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE VILLALBA, PUERTO RICO MANUFACTURING FACILITY.
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