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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 17-10: AAMI / ANSI / ISO 14708-3 2008-01-01, implants for surgery - active implantable medical devices part 3: implantable neurostimulators. (Neurology)

Date of Standard: 2008. 
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
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Implanted Nerve Stimulators
Processes Affected:
510(k), PMA, IDE, PDP, HDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd) Class f OLM
Unclassified Implanted Subcortical Electrical Stimulator (Motor Disorders) Class f MRU
Unclassified Stimulator, Autonomic Nerve, Implanted (Depression) Class 3 MUZ
Unclassified Stimulator, Electrical, Implanted, For Parkinsonian Tremor Class 3 MHY
§876.5270 Stimulator, Electrical, Implantable, For Incontinence Class 3 EZW
§882.5820 Implanted Cerebellar Stimulator Class 3 GZA
§882.5830 Implanted Diaphragmatic/Phrenic Nerve Stimulator Class 3 GZE
§882.5840 Stimulator, Intracerebral/Subcortical, Implanted Class 3 GYZ
§882.5850 Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation Class 3 GZD
§882.5860 Stimulator, Neuromuscular, Implanted Class 3 GZC
§882.5880 Stimulator, Spinal-Cord, Implanted (Pain Relief) Class 2 GZB
FDA Technical Contacts:
 Michael Hoffmann
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1434
  Silver Spring MD 20993
  301/796-6476
  email: michael.hoffmann@fda.hhs.gov
 Kristen Bowsher
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2454
  Silver Spring MD 20993
  301/796-6448
  email: kristen.bowsher@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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