| 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. |
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| Trade Name | CORDIS WEBSTER DIAGNOSITIC/ABLATION DEFLECTABLE TIP CATHETER & CATHETER-THERMOCOUPLE OR THERMISTOR |
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| Classification Name | catheter, electrode recording, or probe, electrode recording |
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| Generic Name | radiofrequency diagnostic/ablation catheter |
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| Regulation Number | 870.1220 |
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| Applicant | CORDIS WEBSTER, INC. |
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| PMA Number | P950005 |
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| Supplement Number | S003 |
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| Date Received | 07/27/1998 |
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| Decision Date | 01/26/1999 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | labeling change - indications |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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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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