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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 SQ ARRAY XP SUBCUTANEOUS LEAD,SQ PATCH LEAD, EPICARDIAL PATCHES
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead; accessory stylets
ApplicantGUIDANT CORP.
PMA NumberP910073
Supplement NumberS031
Date Received01/14/2000
Decision Date04/11/2000
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an extra lead port to the the endotak sq array xp subcutaneous lead model 0049 and a modified df-1 terminal of: the endotak sq array xp subcutaneous lead model 0049; endotak sq patch lead model 0047; endotak sq array subcutaneous lead model 0049; df-1 lead adapters models 6833, 6835, 6931 and the epicardial patches models 0067, 0068, which consists of a shorter terminal pin, a counter bore in the terminal pin and a modified coil transition.
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