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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 RELIANCE IS-I PASSIVE FIXATION
Classification Namepermanent defibrillator electrodes
Generic Nametransvenous defibrillation lead; accessory stylets
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP910073
Supplement NumberS091
Date Received12/14/2010
Decision Date01/05/2012
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
Approval for drug material and supplier changes as well as distal tip design changes.
Approval Order Approval Order
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