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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 RELIANCE FAMILY OF LEADS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910073
Supplement NumberS062
Date Received01/06/2006
Decision Date04/28/2006
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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