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Recognized Consensus Standards

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Recognition List Number: 025 FR 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 Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
Implantable pacemakers, pacemakers lead and pacemakers lead adapters
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Quality System Regulation
Type of Standard:
 International
Extent of Recognition:
Complete standard
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
§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
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
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
* 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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