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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 NameDIAGNOSTIC/ABLATION DEFLECTABLE BRAIDED-TIP CATHETER (WITHOUT THERMOCOUPLE) & CELSIUS (WITH THERMOCOUPLE)
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Namediagnostic/ablation electrode catheter
Regulation Number870.1220
ApplicantCORDIS WEBSTER, INC.
PMA NumberP950005
Supplement NumberS002
Date Received03/23/1998
Decision Date07/22/1998
Product Code
DRF[ Registered Establishments with DRF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 7 fr and 8 fr braided tip version of the diagnostic/ablation deflectable tip catheter (with and without temperature sensors).
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