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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/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS AND TEMPERATURE CABLES
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Nameradiofrequency ablation catheter, electrode recording catheter
Regulation Number870.1220
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP950005
Supplement NumberS014
Date Received05/29/2001
Decision Date06/27/2001
Product Code
DRF[ Registered Establishments with DRF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing site located at biosense webster, inc. , chihuahua, mexico.
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