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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCRT LEADS (MODELS 1156T, 1158Y AND 1258T).
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS182
Date Received03/18/2011
Decision Date05/11/2011
Product Code OJX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A DIMENSIONAL CHANGE TO THE IS-1 CONNECTOR FRONT SEAL.
Post-Approval StudyShow Report Schedule and Study Progress
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