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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEZ STEER BI-DIRECTIONAL NON NAV 4 MM TIP WITH THERMOCOUPLE, 7F EZ NON-NAV CATHETER W/4MM TIP ELECTRODE AND THERMISTOR
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP950005
Supplement NumberS044
Date Received04/26/2013
Decision Date05/29/2013
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.
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