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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 RELIANCE FAMILY OF LEADS
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 NumberS062
Date Received01/06/2006
Decision Date04/28/2006
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 TOLERANCE CHANGE TO THE ELECTRODE BASE DIAMETER, AN INCREASE IN THE ELECTRODE BASE DIAMETER, A TOLERANCE CHANGE TO THE ELECTRODE SHELL BEARING SURFACES, AND A MODIFICATION TO THE O-RING SEAT IN THE ELECTRODE SHELL TO ALL ACTIVE-FIXATION ENDOTAK RELIANCE LEADS.
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