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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 II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER THERMOCOUPLE OR THERMISTOR
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Nameradiofrequency daignostic/ablation catheter
Regulation Number870.1220
ApplicantCORDIS WEBSTER, INC.
PMA NumberP950005
Supplement NumberS007
Date Received11/26/1999
Decision Date03/13/2000
Product Code
DRF[ Registered Establishments with DRF ]
Docket Number N
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a six-month shelf life.
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