BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

    PMA: P000058 · Supplement: S058 · Decision Jan 27, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
    Trade Name
    INFUSE(R) BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
    PMA Number
    P000058
    Supplement Number
    S058
    Device Class
    FDA Class 3
    Product Code
    NEK
    Generic Name
    Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 27, 2015
    Date Received
    October 29, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE PACKAGE INSERT AND PATIENT INFORMATIONBROCHURE (MODIFICATION OF THIS DOCUMENT WAS SUBSEQUENTLY WITHDRAWN) AS FOLLOWS:1) ADDITION OF WARNING AND PRECAUTION LANGUAGE RELATED TO DATA GENERATED FROM YOUR CERVICALSPINE STUDY; 2) CLARIFICATION TO THE POSTERIOR BONE FORMATION PRECAUTION; 3) REVISION TO THE RETROGRADE EJACULATION WARNING LANGUAGE; 4) ORGANIZATION OF THE WARNINGS INTO SIMILAR GROUPS OF ISSUES;5) REPLACEMENT OF ECTOPIC BONE FORMATION WITH HETEROTOPIC OSSIFICATION; 6) ADDITION OF SEVERAL ADDITIONAL POTENTIAL ADVERSE EVENTS; AND7) ALPHABETIZATION OF THE POTENTIAL ADVERSE EVENTS.

    Classifications

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

    Product Code Device Name
    NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction