TACHOS ATX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND PROGRAMMER SOFTWARE
FDA premarket approval P000009/S007 · decided 2003-05-29
Approval details
- PMA number
- P000009
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TACHOS ATX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND PROGRAMMER SOFTWARE
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- Biotronik, Inc.
- Date received
- 2002-12-19
- Decision date
- 2003-05-29
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR MODIFICATIONS TO THE TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME, TACHOS ATX AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING ARRHYTHMIAS. THE DEVICE IS INDICATED FOR USE IN ICD PATIENTS EITHER WITH ATRIAL TACHYARRHYTHMIAS OR WHO ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.
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510(k) clearances by this applicant
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