Atlas FDA

BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

FDA premarket approval P000009/S048 · decided 2012-03-15

Approval details

PMA number
P000009
Supplement
S048
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Applicant
Biotronik, Inc.
Date received
2012-02-17
Decision date
2012-03-15
Days to decision
27 days
Decision code
APPR
Product code
NIK
Advisory committee
Cardiovascular
Expedited review
No
Location
Lake Oswego, OR
Statement
APPROVAL FOR THE PROGRAMMER APPLICATION SOFTWARE VERSION (PSW 1101.U1.

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510(k) clearances by this applicant

RecordFirmDate
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BIOMONITOR IIIm, BIOMONITOR III (K221856)Biotronik, Inc.2022-07-27