LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T
FDA premarket approval P050023/S028 · decided 2010-01-22
Approval details
- PMA number
- P050023
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- Biotronik, Inc.
- Date received
- 2009-11-25
- Decision date
- 2010-01-22
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR A SOFTWARE UPGRADE TO VERSION 902.U/1. THIS SOFTWARE IS USED IN THE ICS 3000 SYSTEM TO PROGRAM AND INTERROGATE ALL OF BIOTRONIK¿S US MARKET RELEASED BRADYCARDIA AND TACHYCARDIA PACEMAKERS.
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510(k) clearances by this applicant
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