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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 MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantAbbott Medical
15900 valley view court
sylmar, CA 91335
PMA NumberP030054
Supplement NumberS049
Date Received02/05/2007
Decision Date07/25/2007
Product Code NIK 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR DISTAL TIP MODIFICATIONS TO THE QUICKSITE LEAD FAMILY TO REDUCE THE LENGTH OF RIGID SECTIONS AND INCREASE LEAD FLEXIBILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUICKFLEX MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS. QUICKFLEX LEADS ARE 6 FRENCH, TRANSVENOUS, STEROID ELUTING, BIPOLAR, IS-1 COMPATIBLE, S-SHAPED CURVE, PASSIVE FIXATION LEADS INTENDED FOR PERMANENT SENSING AND PACING OF THE LEFT VENTRICLE WHEN USED WITH A COMPATIBLE ST. JUDE MEDICAL?S BIVENTRICULAR SYSTEM.
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