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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
ApplicantST. JUDE MEDICAL
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.
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