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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 NameCELSIUS DS CATHETER, NAVISTAR DS CATHETER, NAVISTAR RMT DS CATHETER, EZ STEER NAY DS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency ablation catheter; electrode recording catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP010068
Supplement NumberS032
Date Received03/21/2013
Decision Date07/22/2013
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the transfer of the grinding process from irwindale, california manufacturing facility to juarez, mexico manufacturing facility.
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