BEUDAMED
    Product Code: OSR FDA class 3

    Pacemaker/Icd/Crt Non-Implanted Components

    Unknown

    The Pacemaker/ICD/CRT Non-Implanted Components (product code OSR) are external components that provide programming, interrogation, printing, remote monitoring, and communication between a cardiac pulse generator and the health care provider. These components enable clinicians to configure and monitor implanted cardiac rhythm management devices. As an FDA Class 3 device without an assigned regulation number, it requires Premarket Approval (PMA) to demonstrate safety and effectiveness, and is reviewed by the Cardiovascular panel. Despite being non-implanted components, the product code is flagged as implant-associated due to the broader system it supports. It is not flagged as life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    34
    Registration Numbers
    34
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    OSR
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.

    FEI Numbers

    This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.