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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 Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation catheter
PMA NumberP960016
Supplement NumberS033
Date Received09/27/2010
Decision Date01/07/2011
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following: for only the unidirectional livewire tc model - a modification of the tip attachment design and change of distal tip heat shrink tubing material from ptfe to pte. For both the unidirectional and bidirectional livewire tc models - automation of the epoxy mixing and application process during assembly of the pull wire, removal of in-process pull test requirement, increase in the length tolerance of the flat wire by 0. 1 inches and automation of the dispensing of braze paste.