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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, PRODIGY IPG, SERVICE KIT-PACEMAKER REPAIR KIT
Classification Namepulse generator, permanent, implantable
ApplicantMEDTRONIC, INC.
PMA NumberP890003
Supplement NumberS278
Date Received05/17/2013
Decision Date07/23/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an increase in the storage shelf life of the tyvek lid component, which includes the adhesive coating, used in the medtronic cardiac rhythm disease management products from 18 months to 48 months.
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