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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.
 
DeviceENDOTAK(R) LEAD SYSTEM
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 NumberS015
Date Received05/01/1995
Decision Date11/27/1995
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE DECREASE IN THE LEAD BODY DIAMETER TO BE A MAXIMUM DIAMETER OF 10 FRENCH AND MODIFICATIONS IN THE LEAD COMPONENTS - THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENDOTAK DSP LEAD MODELS 0092, 0093, 0094, 0095, 0096, 0097, 0123, AND 0125
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