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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 NameCAPSUREFIX MRI LEAD
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namemri ipg
ApplicantMEDTRONIC, INC.
PMA NumberP090013
Supplement NumberS155
Date Received08/27/2014
Decision Date09/24/2014
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 Yes
Approval Order Statement 
Increase in the staging duration for the sleeveheads, couplers, and retainers and for the usage of an unheated heptane bath instead of a heated heptane bath.
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