| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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3-186
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| Standard | |
ISO 14708-2 Third edition 2019-09
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers |
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Scope/AbstractThis document specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.
The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance.
This document was designed for bradyarrhythmia pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1).
The electrical characteristics of the implantable pulse generator or lead are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies.
Any features of an active implantable medical device intended to treat tachyarrhythmias are covered by ISO 14708-6.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined. |
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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.
Note: Some necessary testing for implantable cardiac leads is not addressed in this standard. For example, the standard doesn't cover distal tip fatigue testing for an expected 10 years of device use. We encourage you to contact the review division regarding appropriate testing for your device. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| N/A |
Implantable Pulse Generator, Pacemaker (Non-Crt)
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Class 3
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LWP
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| N/A |
Implantable Cardioverter Defibrillator (Non-Crt)
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Class 3
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LWS
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| N/A |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
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Class 3
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NIK
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| N/A |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
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Class 3
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NKE
|
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Relevant FDA Guidance and/or Supportive Publications*
Electromagnetic Compatibility (EMC) of Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued June 2022.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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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. |
