Recognition List Number: 025 Publication Date: 10/04/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-82: ISO 5841-3:2000 Technical Corrigendum 1 2003-11-15, Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers, Technical Corrigendum 1. (Cardiovascular)
Date of Standard: 2003. |
| 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: |
| Implantable pacemakers, pacemakers lead and pacemakers lead adapters |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Quality System Regulation |
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| Type of Standard: |
| International |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes |
Class 3 |
NVN |
| Unclassified |
Permanent Defibrillator Electrodes |
Class 3 |
NVY |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.3680 |
Electrode, Pacemaker, Temporary |
Class 2 |
LDF |
| §870.3680 |
Electrode, Pacing And Cardioversion, Temporary, Epicardial |
Class 2 |
NHW |
| §870.3680 |
Permanent Pacemaker Electrode |
Class 3 |
DTB |
| |
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| Relevant Guidance: |
| "Guidance for the Submission of Research and Marketing Applications for Permanant Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions." November 2000 |
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| FDA Technical Contact: |
| 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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