LUMOS VR-T AND LUMOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH 502.U ICS PROGRAMMER SOFTWARE, A-K00.4.U EPR/...
FDA premarket approval P000009/S016 · decided 2005-08-11
Approval details
- PMA number
- P000009
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LUMOS VR-T AND LUMOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH 502.U ICS PROGRAMMER SOFTWARE, A-K00.4.U EPR/...
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- Biotronik, Inc.
- Date received
- 2005-06-16
- Decision date
- 2005-08-11
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL TO IMPLEMENT INTRACARDIAC ELECTROGRAM (IEGM) SNAPSHOTS OF TACHYCARDIA EVENTS INTO HOME MONITORING TRANSMISSIONS. IN ORDER TO ACCOMPLISH THIS, YOU HAVE REQUESTED THE APPROVAL OF THE LUMOS FAMILY OF ICDS PROGRAMMER SOFTWARE UPGRADES, AND AN UPGRADE TO THE CURRENTLY MARKETED HOME MONITORING SERVICE CENTER.
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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 |