Recognized Consensus Standards

Recognition List Number: 022 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 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
Regulation Number	Device Name	Device Class	Product Code
§876.5270	Stimulator, Electrical, Implantable, For Incontinence	Class 3	EZW
Regulation Number	Device Name	Device Class	Product Code
§882.5820	Implanted Cerebellar Stimulator	Class 3	GZA
Regulation Number	Device Name	Device Class	Product Code
§882.5830	Implanted Diaphragmatic/Phrenic Nerve Stimulator	Class 3	GZE
Regulation Number	Device Name	Device Class	Product Code
§882.5840	Stimulator, Intracerebral/Subcortical, Implanted	Class 3	GYZ
Regulation Number	Device Name	Device Class	Product Code
§882.5850	Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation	Class 3	GZD
Regulation Number	Device Name	Device Class	Product Code
§882.5860	Stimulator, Neuromuscular, Implanted	Class 3	GZC
Regulation Number	Device Name	Device Class	Product Code
§882.5880	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Class 2	GZB

Relevant Guidance:

There is no relevant guidance developed at this time.

FDA Technical Contacts:

Stephen Hinckley   FDA/CDRH/ODE   9200 Corporate Blvd., HFZ-410   Rockville MD 20850   240/276-3606   Email: stephen.hinckley@fda.hhs.gov

Laurence Coyne   FDA/CDRH/ODE   9200 Corporate Blvd., HFZ-410   Rockville MD 20850   240/276-3743   Email: laurence.coyne@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