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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 NameCONSULTA CRT-P, SYNCRA CRT-P
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMEDTRONIC, INC.
PMA NumberP010015
Supplement NumberS191
Date Received03/04/2013
Decision Date03/20/2013
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a battery burn-in process to the universal burn-in test system processing and inspection methods and associated software.
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