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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 & SYNCRA CRT-PS IMPLANTABLE PULSE GENERATOR WITH CARDIAC RESYNCHRONIZATION
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Applicant MEDTRONIC INC.
PMA NumberP010015
Supplement NumberS084
Date Received03/31/2010
Decision Date03/22/2011
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
Approval for the consulta crt-p c4tr01 and syncra crt-p c2tr01 implantable pulse generators with cardiac resynchronization, software model 9995 (version 7. 3), carelink monitor models 2490g and model 2491 ddma.
Approval Order Approval Order
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