LUMAX 300 DR-T,LUMAX 340 DR-T, LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T, LUMAX 540 DR-T, LUMAX 500 VR-T, LUMAX 540
FDA premarket approval P050023/S059 · decided 2013-01-31
Approval details
- PMA number
- P050023
- Supplement
- S059
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LUMAX 300 DR-T,LUMAX 340 DR-T, LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T, LUMAX 540 DR-T, LUMAX 500 VR-T, LUMAX 540
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- Biotronik, Inc.
- Date received
- 2012-12-21
- Decision date
- 2013-01-31
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE UPDATES TO THE HOME MONITORING SERVICE CENTER WITH 5 SOFTWARE VERSIONS, V3.8.1, V3.9.0, V3.10.0, V3.11.0, V3.12.0; AND THE CARDIOMESSENGER II9-LLT)
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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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| Pantera Pro; Pantera LEO (K242969) | Biotronik, Inc. | 2024-10-25 |
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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 |