LUMAX FAMILY OF ICDS AND CRT-DS
FDA premarket approval P050023/S034 · decided 2010-08-04
Approval details
- PMA number
- P050023
- Supplement
- S034
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LUMAX FAMILY OF ICDS AND CRT-DS
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- Biotronik, Inc.
- Date received
- 2010-06-29
- Decision date
- 2010-08-04
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE TANTALUM HIGH VOLTAGE CAPACITORS (GB 80413) FOR LUMAX 340 AND LUMAX 540 ICD/CRT-D 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 |