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U.S. Department of Health and Human Services

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 3-119: ISO 5841-3 Third edition 2013-04-15, implants for surgery - cardiac pacemakers - part 3: low-profile connectors (is-1) for implantable pacemakers. (Cardiovascular)

Date of Standard: 2013. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
Implantable pacemakers, pacemaker lead and pacemaker lead adapters
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Quality System Regulation
Type of Standard:
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Device Name Device
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
§870.3620 Pacemaker Lead Adaptor Class 2 DTD
§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." DRAFT November 2000
FDA Technical Contact:
 Mitchell J. Shein
  10903 New Hampshire Avenue Building 66, Room 1316
  Silver Spring MD 20993
  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