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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.
 
DeviceQUICKFLEX OF LEFT HEART LEADS
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Generic Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP030054
Supplement NumberS158
Date Received06/30/2010
Decision Date08/05/2010
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a modified connector ring on quickflex model 1156t and 1158t left heart leads.
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