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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 PATCH LEAD/SQ ARRAY LEAD/SQ ARRAY XP/SMALL & LARGE PATCH LEADVENTAK NINI III/IV/ AICD PULSE GENERATORS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator systems
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP910077
Supplement NumberS100
Date Received12/16/2009
Decision Date01/12/2010
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the biological indicator used for the sterilization process.
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