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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 FIX LEAD & REVO MRI IPG
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Applicant MEDTRONIC INC.
PMA NumberP090013
Supplement NumberS032
Date Received07/08/2011
Decision Date08/04/2011
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Software upgrade for the manufacturing execution system.
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