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 | NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER |
Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
Regulation Number | 870.1220 |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990025 |
Supplement Number | S002 |
Date Received | 12/11/2000 |
Decision Date | 09/26/2001 |
Product Code |
DRF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXPANDING THE INDICATIONS FOR USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NAVISTART DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER AND IS INDICATED A FOLLOWS: THE BIOSENSE WEBSTER NAVI-STAR DIAGNOSTIC/ABLATION CATHETER, AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGICAL MAPPING, AND FOR USE WITH A COMPATIBLE RF GENERATOR IN ADULTS AND CHILDREN 4 YEARS OF AGE AND OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS. WHEN USED WITH THE CARTO EP NAVIGATION SYSTEM, THE NAVI-STAR DIAGNOSTIC/ABLATION CATHETER PROVIDES LOCATION INFORMATION. |
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