Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-58: AAMI / ANSI / ISO 5840:2005/(R)2010, Cardiovascular implants - Cardiac valve prostheses. (Cardiovascular)
Date of Standard: 2010. |
| 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: |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation |
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| Type of Standard: |
| Vertical |
| Extent of Recognition: |
| Complete standard and any annexes, except for exclusions, differences, and additions in the relevant guidance. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Heart-Valve, Allograft |
Class 3 |
MIE |
| Unclassified |
Heart-Valve, Mechanical |
Class 3 |
LWQ |
| Unclassified |
Heart-Valve, Non-Allograft Tissue |
Class 3 |
LWR |
| Unclassified |
Pulmonic Valved Conduit |
Class f |
MWH |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Class f |
NPV |
| §870.3925 |
Replacement Heart-Valve |
Class 3 |
DYE |
| |
|
| Relevant Guidance: |
| Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications |
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| FDA Technical Contact: |
| Carolyn Vaughan |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1230 |
| Silver Spring MD 20993 |
| 301/796-6338 |
| Email: carolyn.vaughan@fda.hhs.gov |
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