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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 Nameprogrammer recorder monitor (prm) for implantable pulse generators
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS032
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
Recalls CDRH Recalls
Approval Order Statement 
Approval for an extra lead port to 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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