| ANSI AAMI ISO 25539-1: 2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
| Recognition Number | Cardiovascular |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 3-157 |
| Extent | Complete standard |
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| STG | Cardiovascular |
| FDA Tech | Dorothy Abel FDA/OMPT/CDRH/ODE/DCD/VSDB/ 301-796-6366 dorothy.abel@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
25539-1 specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this document. This document can be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
| Regulation Number | Device Name | Device Class | Product Code |
| Unclassified | Coronary Covered Stent | Class f | NIV |
| Unclassified | System, Endovascular Graft, Aortic Aneurysm Treatment | Class 3 | MIH |
| There is no relevant guidance developed at this time. |