Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-114: ISO 5841-3 Second edition 2000-10-15, Implants for Surgery - Cardiac Pacemakers - Part 3: Low-Profile Connectors (IS-1) for Implantable Pacemakers. (Cardiovascular)
Date of Standard: 2000. |
| 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, pacemaker lead and pacemaker 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 |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Class 3 |
NIK |
| Unclassified |
Defibrillator, Implantable, Dual-Chamber |
Class 3 |
MRM |
| 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 |
| Unclassified |
Pulse Generator, Permanent, Implantable |
Class 3 |
NVZ |
| Unclassified |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Class 3 |
LWO |
| Unclassified |
Pulse-Generator, Single Chamber, Single |
Class 3 |
LWW |
| §870.3610 |
Implantable Pacemaker Pulse-Generator |
Class 3 |
DXY |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.3620 |
Pacemaker Lead Adaptor |
Class 2 |
DTD |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §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." DRAFT 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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| * In the United States, copies of this standard can be obtained from: |
| American National Standards Institute (ANSI)* |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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