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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.
 
DeviceQUICKFLEX OF LEFT HEART LEADS
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS158
Date Received06/30/2010
Decision Date08/05/2010
Product Code OJX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MODIFIED CONNECTOR RING ON QUICKFLEX MODEL 1156T AND 1158T LEFT HEART LEADS.
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