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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 SP & CAPSURE Z
Classification Namepermanent defibrillator electrodes
Generic Nameelectrode, pacemaker, permanent
ApplicantMEDTRONIC VASCULAR
PMA NumberP850089
Supplement NumberS056
Date Received06/27/2007
Decision Date07/27/2007
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change in the molding vendor for the is-1 connector sleeve component from medtronic puerto rico operations company to fmi, inc.
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