TACHOS DR, TACHOS DR- ATRIAL TX,TACHOS ATX
FDA premarket approval P000009/S001 · decided 2001-03-05
Approval details
- PMA number
- P000009
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TACHOS DR, TACHOS DR- ATRIAL TX,TACHOS ATX
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- Biotronik, Inc.
- Date received
- 2000-12-13
- Decision date
- 2001-03-05
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR A NEW ICD SYSTEM WHICH INCLUDES THE FOLLOWING: TACHOS DR ICD (MODEL 335572), TACHOS DR TEST HOUSING (MODEL 122068), AND TACHOS DR AND TMS 1000 APPLICATION SOFTWARE I-HDR.0.U (MODEL 334802). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TACHOS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTICULAR ARRHYTHMIAS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOMONITOR IV (471155) (K261074) | Biotronik, Inc. | 2026-05-01 |
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| Oscar Peripheral Multifunctional Catheter system (K241711) | Biotronik, Inc. | 2024-07-11 |
| BIOMONITOR IV (K230375) | Biotronik, Inc. | 2023-05-19 |
| Passeo-35 Xeo Peripheral Dilatation Catheter (K222065) | Biotronik, Inc. | 2023-02-16 |
| BIOMONITOR IIIm, BIOMONITOR III (K221856) | Biotronik, Inc. | 2022-07-27 |