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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 SENSE BIPOLAR LEAD
Classification Namepermanent defibrillator electrodes
Generic Nameelectrode, pacemaker, permanent
Applicant MEDTRONIC INC.
PMA NumberP830061
Supplement NumberS085
Date Received01/14/2013
Decision Date02/07/2013
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing changes at the medtronic singapore operations (mso) manufacturing facility: proteus 3. 6 and self-test 3. 3 final function testier update, sqm version 3. 3. 3, facotryworks version 7. 8, aats version 5. 0 update, and thermal processing of epoxy resin.
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