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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.
 
DeviceLIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER (EPTC) EXT CBL, SAFIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, EXT CBL, S
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
St. Jude Medical
14900 minnetonka ind rd
minnetonka, MN 55345
PMA NumberP960016
Supplement NumberS040
Date Received12/17/2012
Decision Date02/19/2013
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design modifications to the materials in the extension cables compatible with the livewire tc steerable and safire steerable cardiac ablation catheters.
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