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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 NameCRT LEADS (MODELS 1156T, 1158Y AND 1258T).
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
PMA NumberP030054
Supplement NumberS182
Date Received03/21/2011
Decision Date05/11/2011
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a dimensional change to the is-1 connector front seal.