BEUDAMED
    Product Code: LWP FDA class 3

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    Unknown

    The Non-CRT Implantable Pacemaker Pulse Generator (product code LWP) is a cardiac device implanted in the chest that delivers electrical impulses to the heart to treat bradycardia (slow heartbeats) through right atrial (RA) and/or right ventricular (RV) pacing therapy as necessary. It is classified as a Class 3 device requiring Premarket Approval (PMA), and is flagged as both an implant and a life-sustaining device, reflecting the critical nature of its cardiac support function. The device is reviewed under the Cardiovascular (CV) panel. No regulation number has been formally assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    35
    Registration Numbers
    35
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    LWP
    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

    These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.

    FEI Numbers

    This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.