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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCAPSURE LEAD, SERVICE KIT PACEMAKER REPAIR KIT
Classification Namepulse generator, permanent, implantable
ApplicantMEDTRONIC, INC.
PMA NumberP890003
Supplement NumberS291
Date Received10/30/2013
Decision Date11/26/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Reduce the exposure time during ethylene-oxide half-cycle testing.
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