Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-85: AAMI / ANSI / ISO 25539-2:2008, Cardiovascular implants - Endovascular devices - Part 2: Vascular stents. (Cardiovascular)
Date of Standard: 2008. |
| Addresses of Standards Organizations: |
| Association for the Advancement of Medical Instrumentation (AAMI) |
| 4301 North Fairfax Drive |
| Suite 301 |
| Arlington, VA 22203 |
| |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
|
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: |
| Vascular Stents regulated by the Division of Cardiovascular Devices |
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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. There are some additional test requirements for submissions to CDRH, including some issues regarding test validation. The 2005 Draft Coronary Drug-Eluting Stent Guidance and Companion documents, 2010 Intravascular Stent Guidance, and 2010 Animal Study Guidance (referenced below) describe in more detail these additional testing recommendations. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Coronary Drug-Eluting Stent |
Class 3 |
NIQ |
| Unclassified |
Stent, Carotid |
Class 3 |
NIM |
| Unclassified |
Stent, Coronary |
Class 3 |
MAF |
| Unclassified |
Stent, Iliac |
Class 3 |
NIO |
| Unclassified |
Stent, Renal |
Class 3 |
NIN |
| Unclassified |
Stent, Superficial Femoral Artery |
Class 3 |
NIP |
| |
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| Relevant Guidance: |
Draft Guidance for Industry: Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies, March 2008
Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, April 18, 2010
Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices, July 29,2010
ASTM F2514-08 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading |
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| FDA Technical Contacts: |
| Ashley Boam |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1555 |
| Silver Spring MD 20993 |
| 301/796-6341 |
| Email: ashley.boam@fda.hhs.gov |
|
| Nicole Ibrahim |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1546 |
| Silver Spring MD 20993 |
| 301/796-5171 |
| Email: nicole.ibrahim@fda.hhs.gov |
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