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Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 3-131: AAMI / ANSI / ISO 27185:2012, cardiac rhythm management devices -- symbols to be used with cardiac rhythm managment device labels, and information to be supplied -- general requirements. (Cardiovascular)

Date of Standard: 2012. 
Addresses of Standards Development 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
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Cardiac rhythm management devices
Processes Affected:
All premarket and postmarket processes
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§870.1750 Generator, Pulse, Pacemaker, External Programmable Class 2 JOQ
§870.3600 Pulse Generator, External Pacemaker, Dual-Chamber Class 3 OVJ
§870.3600 Pulse-Generator, Pacemaker, External Class 3 DTE
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
§870.3630 Analyzer, Pacemaker Generator Function Class 2 DTC
Unclassified Device, Removal, Pacemaker Electrode, Percutaneous Class 3 MFA
Unclassified System, Esophageal Pacing Class 3 LPA
§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
Unclassified Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
Unclassified Implantable Pulse Generator, Pacemaker (Non-Crt) Class 3 LWP
Unclassified Pulse-Generator, Single Chamber, Sensor Driven, Implantable Class 3 LWO
§870.3700 Programmer, Pacemaker Class 3 KRG
§870.3720 Tester, Pacemaker Electrode Function Class 2 DTA
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 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 Pacemaker/Icd/Crt Non-Implanted Components Class 3 OSR
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 System,Pacing,Temporary,Acute,Internal Atrial Defibrillation Class 3 MTE
Unclassified Wearable Automated External Defibrillator Class 3 MVK
§870.5310 Automated External Defibrillators (Non-Wearable) Class 3 MKJ
§870.5310 Over-The-Counter Automated External Defibrillator Class 3 NSA
Relevant Guidance:
Use of Symbols in Labeling of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff
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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