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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 LEAD SYSTEM FAMILY
Generic NamePermanent defibrillator electrodes
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910073
Supplement NumberS105
Date Received07/26/2012
Decision Date10/05/2012
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USE OF A LONGER STERILE BARRIER TYVEK POUCH AS PRIMARY PACKAGING FOR THE BSC CRV LEADS ACCESSORY PRODUCTS.
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