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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.
 
DeviceST. JUDE MEDICAL EPIC HF SYSTEM
Generic Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant
Abbott Medical
15900 valley view court
sylmar, CA 91335
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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