NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER
FDA premarket approval P990025/S002 · decided 2001-09-26
Approval details
- PMA number
- P990025
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Applicant
- Biosense Webster, Inc.
- Date received
- 2000-12-11
- Decision date
- 2001-09-26
- Days to decision
- 289 days
- Decision code
- APPR
- Product code
- DRF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- 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
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510(k) clearances by this applicant
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|---|---|---|
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| CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) (K231207) | Biosense Webster, Inc. | 2023-09-07 |
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