Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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049
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Date of Entry 06/07/2018
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FR Recognition Number
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17-15
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Standard | |
ISO 14708-3 Second edition 2017-04 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators |
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Scope/AbstractISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.
The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§882.5820 |
Implanted Cerebellar Stimulator |
Class 3 |
GZA |
§882.5830 |
Implanted Diaphragmatic/Phrenic Nerve Stimulator |
Class 3 |
GZE |
§882.5840 |
Stimulator, Intracerebral/Subcortical, Implanted |
Class 3 |
GYZ |
§882.5850 |
Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation |
Class 3 |
GZD |
§882.5860 |
Stimulator, Neuromuscular, Implanted |
Class 3 |
GZC |
§882.5880 |
Stimulator, Spinal-Cord, Implanted (Pain Relief) |
Class 2 |
GZB |
§876.5270 |
Stimulator, Electrical, Implantable, For Incontinence |
Class 3 |
EZW |
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Unclassified |
Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd) |
Class f |
OLM |
Unclassified |
Implanted Subcortical Electrical Stimulator (Motor Disorders) |
Class f |
MRU |
Unclassified |
Stimulator, Autonomic Nerve, Implanted (Depression) |
Class 3 |
MUZ |
Unclassified |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Class 3 |
MHY |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |