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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.
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead
PMA NumberP950022
Supplement NumberS034
Date Received12/19/2006
Decision Date03/08/2007
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes: 1)modification to the crimp slug weld tab 2) modification to the distal header assembly 3) modification to the ptfe liner in the is-1 connector leg 4) removal of the ptfe liners in the two df-1 connector legs 5) addition of a df-1 plug accessory to the lead package 6) addition of an extra-soft stylet accessory to the lead package 7) minor modifications to the user manual 8) modified radius specification for the spring stopper component.