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510(k) Data Aggregation

    K Number
    K092371
    Device Name
    SWIFT-LOCK ANCHOR, MODEL 1192
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2009-12-23

    (140 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED NEUROMODULATION SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Swift-Lock™ anchor is intended to be an accessory to the leads component of ANS SCS systems functioning to secure the lead to the fascia or interspinous/supra-spinous ligament.
    Device Description
    Not Found
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    K Number
    K091993
    Device Name
    RAPID PROGRAMMER, VERSION 3.3.0
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.)
    Date Cleared
    2009-07-31

    (29 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED NEUROMODULATION SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer also allows the clinician to optimize performance by leading the patient through a series of device parameter combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.
    Device Description
    The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer also allows the clinician to optimize performance by leading the patient through a series of device parameter combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.
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    K Number
    K090907
    Device Name
    PENTA LEAD KITS, MODELS: 3227-3234
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2009-06-02

    (62 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED NEUROMODULATION SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Advanced Neuromodulation Systems Penta Lead Kits are indicated for the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach and are intended to be used with Advanced Neuromodulation Systems receivers, transmitters, and/or antennae.
    Device Description
    Not Found
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    K Number
    K081208
    Device Name
    CINCH ANCHOR, MODEL 1194
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2008-07-18

    (80 days)

    Product Code
    GZB, GZF
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED NEUROMODULATION SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Cinch™ anchor is intended to be an accessory to the leads component of ANS SCS systems functioning to secure the lead to the fascia or inter-spinous/supraspinous ligament.
    Device Description
    The Cinch™ anchor is intended to be an accessory to the leads component of ANS SCS systems functioning to secure the lead to the fascia or inter-spinous/supraspinous ligament.
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    K Number
    K072462
    Device Name
    WIDE SPACED QUATTRODE LEADS
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2007-10-11

    (41 days)

    Product Code
    GZB, GZF
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED NEUROMODULATION SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. ANS Percutaneous Leads model number 3066, 3161, 3163, 3166, 3169, extension model numbers 3382, 3383, 3341, 3342, 3343, and receiver model number 3408, transmitter model number 3508, and antenna model numbers 1220 and 1230 are also indicated to stimulate electrically peripheral nerves to relieve severe intractable pain.
    Device Description
    Not Found
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    K Number
    K070847
    Device Name
    TRIAL CABLE, 3009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2007-04-11

    (14 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED NEUROMODULATION SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Advanced Neuromodulation Systems, Trial Cable is indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Trial Cable is used as an accessory in the Multiprogram Trial Stimulator System (MTS ™). MTS ™ system is intended to be used with ANS Leads (percutaneous) to deliver targeted paresthesia to single or multiple painful sites for trial stimulation either intraoperatively or post operatively for up to a maximum of thirty days.
    Device Description
    Not Found
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    K Number
    K063080
    Device Name
    TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2006-12-12

    (63 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED NEUROMODULATION SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Advanced Neuromodulation Systems Tripole 8C, Tripole 16C, and Exclaim 8 Lead Kits are indicated for the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach and are intended to be used with Advanced Neuromodulation Systems receivers, transmitters, and/or antennae.
    Device Description
    Not Found
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    K Number
    K053250
    Device Name
    ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2005-12-15

    (24 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED NEUROMODULATION SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Advanced Neuromodulation Systems 90 cm and 110 cm (3100 and 3200 Series) Leads are indicated for the management of chronic pain of the trunk and/or limbs either as the sole mitigating agent, or as an adjunct to other modes of therapy as part of a multidisciplinary approach and are intended for use with Advanced Neuromodulation Systems receivers, IPGs, transmitters, and/or antennae.
    Device Description
    Not Found
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    K Number
    K052374
    Device Name
    RAPID PROGEAMMER 3.0
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2005-11-22

    (84 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED NEUROMODULATION SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer also allows the clinician to optimize performance by leading the patient through a series of device parameter combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.
    Device Description
    This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.
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    K Number
    K052418
    Device Name
    AXXESS BUTTERFLY ANCHOR
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2005-09-26

    (24 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED NEUROMODULATION SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Axxess® Butterfly Anchor accessory is intended to be used with the ANS Axxess percutaneous permanent and trial leads to secure the leads to the interspinous ligament.
    Device Description
    Not Found
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