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510(k) Data Aggregation

    K Number
    K150291
    Device Name
    TYRX Neuro Absorbable Antibacterial Envelope
    Manufacturer
    MEDTRONIC TYRX, INC.
    Date Cleared
    2015-03-27

    (49 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC TYRX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TYRX Neuro Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator or a sacral nerve stimulator securely in order to create a stable environment when implanted in the body. TYRX Neuro Absorbable Antibacterial Envelope contains the antimicrobial agents rifampin and minocycline which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of a pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa, or in conjunction with spinal cord neuromodulators or sacral nerve stimulators implanted laterally to the body midline and slightly superior to the gluteal region. TYRX Neuro Absorbable Antiqacterial Envelope is intended for single patient, one-time use only.
    Device Description
    TYRX 110 Neuro Absorbable Antibacterial Envelope is a fully absorbable, dual component sterile device designed to hold a vagus nerve stimulator (VNS), a deep brain stimulator (DBS), a spinal cord neuromodulator (SCN) or a sacral nerve stimulator (SNS) securely to create a stable environment when implanted in the body. It is constructed of knitted filaments of a commercially available absorbable polymer, Glycoprene II, comprised of glycolide, caprolactone and trimethylene carbonate polymer, and coated with an absorbable polyarylate polymer mixture containing the antimicrobial agents rifampin and minocycline. Rifampin and minocvcline have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of an implantable electronic device. This device is to be used in a healthcare facility/hospital by qualified personnel experienced in the procedure of VNS, DBS, SCN, or SNS implantation.
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    K Number
    K142611
    Device Name
    TYRX Neuro Absorbable Antibacterial Envelope
    Manufacturer
    MEDTRONIC TYRX, INC.
    Date Cleared
    2014-12-31

    (106 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC TYRX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TYRX™ Neuro Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator or spinal cord neuromodulator securely in order to create a stable environment when implanted in the body. TYRX™ Neuro Absorbable Antibacterial Envelope contains the antimicrobial agents rifampin and minocycline which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of a pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa, or spinal cord neuromodulators implanted laterally to the body midline and slightly superior to the gluteal region. TYRX™ Neuro Absorbable Antibacterial Envelope is intended for single patient, one-time use only.
    Device Description
    TYRX ™ Neuro Absorbable Antibacterial Envelope is a fully absorbable , dual component sterile device designed to hold a vagus nerve stimulator or spinal cord neuromodulator securely to create a stable environment when implanted in the body. It is constructed of knitted filaments of a commercially available absorbable polymer, Glycoprene II, comprised of glycolide, caprolactone and trimethylene carbonate polymer, and coated with an absorbable polyarylate polymer mixture containing the antimicrobial agents rifampin and minocycline. Rifampin and minocycline have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of an implantable electronic device is to be used in a healthcare facility/hospital by personnel experienced in the procedure of vagus nerve or spinal cord neuromodulator implantation.
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