BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Intervertebral Disc

    PMA: P050010 · Decision Aug 14, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73

    Basic Information

    Device Name
    Prosthesis, Intervertebral Disc
    Trade Name
    PRODISC -L TOTAL DISC REPLACEMENT DEVICE
    PMA Number
    P050010
    Device Class
    FDA Class 3
    Product Code
    MJO
    Generic Name
    Prosthesis, intervertebral disc
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 14, 2006
    Date Received
    March 15, 2005
    Expedited Review
    N
    Docket Number
    06M-0343

    Advisory Committee Statement

    APPROVAL FOR THE PRODISC-L TOTAL DISC REPLACEMENT. THE DEVICE IS INDICATED FOR SPINAL ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L3-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS SHOULD HAVE NO MORE THAN GRADE 1 SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. PATIENTS RECEIVING THE PRODISC-L TOTAL DISC REPLACEMENT SHOULD HAVE FAILED AT LEAST SIX MONTHS OF CONSERVATIVE TREATMENT PRIOR TO IMPLANTATION OF THE PRODISC-L TOTAL DISC REPLACEMENT.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MJO Prosthesis, Intervertebral Disc