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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 THERMOCOOL CATHETER, CELSIUS RMT THERMOCOOL CATHETER, CELSIUS RMT THERMOCOOL
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP030031
Supplement NumberS050
Date Received03/21/2013
Decision Date07/22/2013
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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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