LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T

FDA premarket approval P050023/S048 · decided 2012-05-04

Approval details

PMA number: P050023
Supplement: S048
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Trade name: LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Applicant: Biotronik, Inc.
Date received: 2011-11-02
Decision date: 2012-05-04
Days to decision: 184 days
Decision code: APPR
Product code: MRM
Advisory committee: Cardiovascular
Expedited review: No
Location: Lake Oswego, OR
Statement: APPROVAL FOR THE ADDITION OF WIRELESS TELEMETRY AND PACING VECTOR CHANGES.

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