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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 DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER WITH 5MM TIP ELECTRODE
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Nameradiofrequency diagnostic/ablation catheter
Regulation Number870.1220
ApplicantCORDIS WEBSTER, INC.
PMA NumberP950005
Supplement NumberS004
Date Received02/22/1999
Decision Date04/05/1999
Product Code
DRF[ Registered Establishments with DRF ]
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 the 7 fr and 8 fr catheters incorporating a 5mm tip electrode. The device, as modified, will be marketed under the trade name celsius(tm) diagnostic/ablation deflectable braided tip catheter (5mm tip electrode) and is indicated for interruption of accessory av conduction pathways assocated with tachycardia, the treatment of av nodal reentrant tachycardia (avnrt), and creation of complete av nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia. In addition to these indications, the 7 fr catheter is also indicated for persistent junctional reciprocating tachycardia, mahaim fibers, and pediatric patients (age 4 years or older).
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