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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceENDOTAK FAMILY OF ENDOCARDIAL DEFIBRILLATION LEAD MODELS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
BOSTON SCIENTIFIC
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP910073
Supplement NumberS027
Date Received07/26/1999
Decision Date09/29/1999
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified DF-1 terminal of the ENDOTAK(R) series of Endocardial Defibrillation Leads and the Model 6952 Lead Extender, which consists of a shorter terminal pin, a counter bore in the terminal pin, and a modified coil transition.
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