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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 022 FR Publication Date: 09/08/2009 

Part B: Supplementary Information

Recognition Number 17-8: ISO 14708-3 2008-11-15, implants for surgery - active implantable medical devices part 3: implantable neurostimulators. (Neurology)

Date of Standard: 2008. 
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)
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 Contact:
 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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