BELOS A+ AND BELOS A+/T ICD AND KAINOX A+ ICD LEAD (SINGLE-LEAD SYSTEM)
FDA premarket approval P000009/S009 · decided 2003-11-13
Approval details
- PMA number
- P000009
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BELOS A+ AND BELOS A+/T ICD AND KAINOX A+ ICD LEAD (SINGLE-LEAD SYSTEM)
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- Biotronik, Inc.
- Date received
- 2003-07-03
- Decision date
- 2003-11-13
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE LEXOS FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) AND SOFTWARE MODIFICATIONS TO THE BELOS FAMILY OF ICDS, THE CARDIAC AIRBAG-T AND THE MICROPHYLAX ICD. THE NEW DEVICE WILL BE MARKETED UNDER THE TRADE NAME LEXOS VR, LEXOS VR-T, LEXOS DR, LEXOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND PROGRAMMER SOFTWARE (A-K00.1.U/4).
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |