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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 NumberS024
Date Received02/19/1998
Decision Date08/13/1998
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design change to provide higher pacing impedance. Teh device, as modified, will be marketed under the trade name endotak(r) endurance(tm) endocardial defibrillation lead and is indicated for use to provide pacing and rate-sensing and delivery cardioversiona nd defibrillation shocks for aicd automatic implantable cardioverter defibrillator systems.
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