TACHOS DR IMPLANTALBLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM
FDA premarket approval P000009/S002 · decided 2001-09-04
Approval details
- PMA number
- P000009
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TACHOS DR IMPLANTALBLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- Biotronik, Inc.
- Date received
- 2001-08-10
- Decision date
- 2001-09-04
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR CHANGES TO THE EMBEDDED AND PROGRAMMER SOFTWARE FOR THE TACHOS DR. THE NEW VERSION NUMBER FOR THE SOFTWARE CARTRIDGE FOR TACHOS DR/PHYLAX AV/TMS 1000 APPLICATIONS IS I-HDR.0.U/4 (MODEL 338 373). THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME TACHOS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
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510(k) clearances by this applicant
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| BIOMONITOR IV (K230375) | Biotronik, Inc. | 2023-05-19 |
| Passeo-35 Xeo Peripheral Dilatation Catheter (K222065) | Biotronik, Inc. | 2023-02-16 |
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