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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 NameFINISHING WIRE UNIVERSAL
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS013
Date Received04/25/2003
Decision Date06/09/2003
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 modifications to the finishing wire cap section of the commercially available finishing wire universal which will allow it to be compatible with the is-1 terminal pin as well as the lv-1 terminal pin of the easytrak leads. The device, as modified, will be marketed under the trade name finishing wire universal, models 6001-6007 and is indicated for use with guidant coronary vendus leads.
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