LUMAX 500/540 ICDS THORACIC IMPEDANCE
FDA premarket approval P050023/S047 · decided 2011-11-17
Approval details
- PMA number
- P050023
- Supplement
- S047
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LUMAX 500/540 ICDS THORACIC IMPEDANCE
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- Biotronik, Inc.
- Date received
- 2011-08-22
- Decision date
- 2011-11-17
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE ADDITION OF THE THORACIC IMPEDANCE (TI) MEASUREMENT FEATURE TO THE CURRENTLY APPROVED LUMAX 500/540 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION DEFIBRILLATOR DEVICES.
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510(k) clearances by this applicant
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|---|---|---|
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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 |