Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-93: ISO 25539-1:2003 First edition 2001-11-13, AMENDMENT 1 2005-07-15 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses Amendment 1: Test methods. (Cardiovascular)
Date of Standard: 2009. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
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| Devices Affected: |
| Endovascular Systems (includes endovascular grafts, covered stents, and their delivery systems) |
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| Processes Affected: |
| PMA, IDE, PDP, HDE, Design Control Input, Quality System Regulation |
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| Type of Standard: |
| Vertical |
| Extent of Recognition: |
Complete standard
NOTE: This standard identifies critical parameters for endovascular systems and provides guidance on the development of appropriate test methods. It does not contain acceptance criteria for the parameters. |
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| Related CFR Citations and Product Codes: |
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 |
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| Relevant Guidance: |
| There is no relevant guidance at this time. |
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| FDA Technical Contact: |
| Dorothy Abel |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1204 |
| Silver Spring MD 20993 |
| 301/796-6366 |
| Email: dorothy.abel@fda.hhs.gov |
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