Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-109: AAMI / ANSI / ISO 27186:2010, Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements. (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 |
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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: |
| Implantable permanent cardiac pacemaker and defibrillator electrodes (leads) and associated implantable pulse generators, pacemakers, defibrillators, and cardiac resynchronization therapy devices. |
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| Processes Affected: |
| The standard provides dimensional and test requirements which allow interchangeability between implantable leads, pulse generators and defibrillators from different manufacturers |
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| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Class 3 |
NIK |
| Unclassified |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Class 3 |
OJX |
| Unclassified |
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes |
Class 3 |
NVN |
| Unclassified |
Implantable Cardioverter Defibrillator (Non-Crt) |
Class 3 |
LWS |
| Unclassified |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Class 3 |
LWP |
| Unclassified |
Permanent Defibrillator Electrodes |
Class 3 |
NVY |
| Unclassified |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Class 3 |
NKE |
| |
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| Relevant Guidance: |
| Guidance for the submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions: November 1, 2000 |
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| FDA Technical Contacts: |
| Mark Fellman |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1306 |
| Silver Spring MD 20993 |
| 301/796-6357 |
| Email: mark.fellman@fda.hhs.gov |
|
| Mitchell J. Shein |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1316 |
| Silver Spring MD 20993 |
| 301/796-6363 |
| Email: mitchell.shein@fda.hhs.gov |
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