| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | CORDIS WEBSTER DIAGNOSITIC/ABLATION DEFLECTABLE TIP CATHETER & CATHETER-THERMOCOUPLE OR THERMISTOR |
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| Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
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| Regulation Number | 870.1220 |
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| Applicant | Biosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618 |
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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 |
DRF |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | 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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