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Adjunctive Cardiac Amyloidosis Status Indicator

FDA product code SDJ · 3 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2200
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-11-15 – 2025-06-20

The adjunctive cardiac amyloidosis status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting cardiac amyloidosis. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

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