Recognition List Number: 025 Publication Date: 10/04/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-79: ASTM F2079-09, Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents1. (Cardiovascular)
Date of Standard: 2009. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
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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: |
| Balloon-Expandable Vascular Stents |
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| Processes Affected: |
| PMA, PDP, IDE, HDE, Quality System Regulation |
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| Type of Standard: |
| Test Methods, Vertical, International |
| Extent of Recognition: |
Complete standard
The purpose of this test is to quantify the percentage by which the diameter of a stent decreases from its expanded diameter while still on the delivery balloon to its relaxed diameter after deflating the balloon. This test is appropriate for stents manufactured from a material that is plastically deformed when the stent's diameter is increased from its predeployed size to its postdeployed size by mechanical means. This test may be performed in air at room temperature unless there is a known temperature dependence of the material, in which case, the temperature at which the test is conducted shall be stated in the report. |
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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: |
Guidance for Industry and FDA Staff -- Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - January 13, 2005
Draft Guidance for Industry and FDA Staff ¿ Coronary Drug-Eluting Stents ¿ Nonclinical and Clinical Studies. March 2008. |
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| FDA Technical Contacts: |
| Heather Agler |
| FDA/CDRH/OCD |
| 10903 New Hampshire Avenue Building 66, Room 5572 |
| Silver Spring MD 20993 |
| 301/796-6340 |
| Email: heather.agler@fda.hhs.gov |
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| Kenneth Cavanaugh |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1208 |
| Silver Spring MD 20993 |
| 301/796-6377 |
| Email: kenneth.cavanaugh@fda.hhs.gov |
|
| Hina Pinto |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1106 |
| Silver Spring MD 20993 |
| 301/796-6351 |
| Email: hina.pinto@fda.hhs.gov |
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