LUMAX 300/340; 500/540; 540 VR-T DX; 600/640;700/740 FAMILY, IFORIA 7/5 FAMILY; ILESTO 7/5/FAMILY
FDA premarket approval P050023/S069 · decided 2013-09-26
Approval details
- PMA number
- P050023
- Supplement
- S069
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LUMAX 300/340; 500/540; 540 VR-T DX; 600/640;700/740 FAMILY, IFORIA 7/5 FAMILY; ILESTO 7/5/FAMILY
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- Biotronik, Inc.
- Date received
- 2013-08-15
- Decision date
- 2013-09-26
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE APPLICATION SOFTWARE VERSION PSW 1301.U OF THEPROGRAMMER MODELS RENAMIC AND ICS 3000 FOR THE DEVICES.
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510(k) clearances by this applicant
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|---|---|---|
| BIOMONITOR IV (471155) (K261074) | Biotronik, Inc. | 2026-05-01 |
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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 |