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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 LEAD SYSTEM FAMILY
Classification Namepermanent defibrillator electrodes
Generic Nametransvenous defibrillation lead; accessory stylets
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP910073
Supplement NumberS105
Date Received08/29/2012
Decision Date10/05/2012
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product Yes
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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