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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.
 
Trade NameEASYTRAK LEAD MODELS IS-1 4535/4536/4537/4538 CORONARY VENOUS STEROID-ELUTING SINGLE-ELECTRODE PACE/SENSE LEAD
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namepacing lead suture sleeve
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS010
Date Received03/12/2003
Decision Date06/13/2003
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for change from a lv-1 lead connector to an is-1 lead connector design. The device, as modified, will be marketed under the trade name easytrak is-1 lead, and is indicated for chronic left ventricular pacing and sensing via the coronary veins when used in conjunction with a compatible cardiac resynchronization therapy (crt) device.
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