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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 NameENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namenonthorocotomy leads for cardioverter
ApplicantGUIDANT CORP.
PMA NumberP910073
Supplement NumberS023
Date Received10/16/1997
Decision Date11/17/1997
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the is-1 terminal of the dsp lead.
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