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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 NumberS190
Date Received02/26/2013
Decision Date05/24/2013
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the mycarelink patient monitor models 24950, 24951, reader model 24955, and accessories, which support the devices.
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