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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 NameCORDIS WEBSTER DIAGNOSITIC/ABLATION DEFLECTABLE TIP CATHETER & CATHETER-THERMOCOUPLE OR THERMISTOR
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Nameradiofrequency diagnostic/ablation catheter
Regulation Number870.1220
ApplicantCORDIS WEBSTER, INC.
PMA NumberP950005
Supplement NumberS003
Date Received07/27/1998
Decision Date01/26/1999
Product Code
DRF[ Registered Establishments with DRF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expanded indications for use for the 6 fr and 7 fr cordis webster diagnostic/ablation deflectable tip catheters and interface cables. In addition to the previously approved indications for interruption of accessory av conduction pathways associated 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, your ablation system is now approved to treat patients with the following indications for use: 1) pediatric patients (age 4 years or older); 2) patients with persistent junctional reciprocating tachycardia (pjrt); and 3) patients with mahaim fibers.
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