QWIKSTAR DIAGNOSTIC/ABLATION CATHETERS (MODELS D-1229 AND D-1230) AND QWIKSTAR INTERFACE CABLE (MODEL D-1195-12)
FDA premarket approval P990025/S004 · decided 2002-12-18
Approval details
- PMA number
- P990025
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Trade name
- QWIKSTAR DIAGNOSTIC/ABLATION CATHETERS (MODELS D-1229 AND D-1230) AND QWIKSTAR INTERFACE CABLE (MODEL D-1195-12)
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Applicant
- Biosense Webster, Inc.
- Date received
- 2002-04-01
- Decision date
- 2002-12-18
- Days to decision
- 261 days
- Decision code
- APPR
- Product code
- DRF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A NEW INTERFACE CABLE AND DESIGN CHANGES (E.G., ADDITIONAL LOCATION SENSOR) TO THE CATHETER PREVIOUSLY APPROVED UNDER P990025 AND IT'S SUPPLEMENTS, IN ORDER TO ENABLE ADDITIONAL MAPPING CAPABILITIES.
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