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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 LEADS 5038, 5038L, 5038S,IMW14Q,IMW15Q, IMW16Q, IMW17Q, IMW18Q, PRODIGY IPG, 8158
Classification Namepulse generator, permanent, implantable
Applicant MEDTRONIC INC.
PMA NumberP890003
Supplement NumberS255
Date Received08/03/2012
Decision Date08/30/2012
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Modifications to a controlled environment.
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