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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.
 
DeviceST. JUDE MEDICAL EPIC HF SYSTEM
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 NumberS155
Date Received06/22/2010
Decision Date02/11/2011
Product Code
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 new 4. 3-4. 7 fr slit suture sleeve accessory kit to be used with the approved 1258t quickflex ¿ lead.
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