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Found 26 results
510(k) Data Aggregation
K Number
K092371Device Name
SWIFT-LOCK ANCHOR, MODEL 1192
Manufacturer
ADVANCED NEUROMODULATION SYSTEMS
Date Cleared
2009-12-23
(140 days)
Product Code
GZB
Regulation Number
882.5880Why 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
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K Number
K091993Device 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
882.5880Why 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
K090907Device Name
PENTA LEAD KITS, MODELS: 3227-3234
Manufacturer
ADVANCED NEUROMODULATION SYSTEMS
Date Cleared
2009-06-02
(62 days)
Product Code
GZB
Regulation Number
882.5880Why 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
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K Number
K081208Device Name
CINCH ANCHOR, MODEL 1194
Manufacturer
ADVANCED NEUROMODULATION SYSTEMS
Date Cleared
2008-07-18
(80 days)
Product Code
GZB, GZF
Regulation Number
882.5880Why 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
K072462Device Name
WIDE SPACED QUATTRODE LEADS
Manufacturer
ADVANCED NEUROMODULATION SYSTEMS
Date Cleared
2007-10-11
(41 days)
Product Code
GZB, GZF
Regulation Number
882.5880Why 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
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K Number
K070847Device Name
TRIAL CABLE, 3009
Manufacturer
ADVANCED NEUROMODULATION SYSTEMS
Date Cleared
2007-04-11
(14 days)
Product Code
GZB
Regulation Number
882.5880Why 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
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K Number
K063080Device 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
882.5880Why 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
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K Number
K053250Device 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
882.5880Why 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
K052374Device Name
RAPID PROGEAMMER 3.0
Manufacturer
ADVANCED NEUROMODULATION SYSTEMS
Date Cleared
2005-11-22
(84 days)
Product Code
GZB
Regulation Number
882.5880Why 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
K052418Device Name
AXXESS BUTTERFLY ANCHOR
Manufacturer
ADVANCED NEUROMODULATION SYSTEMS
Date Cleared
2005-09-26
(24 days)
Product Code
GZB
Regulation Number
882.5880Why 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
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