Recognition List Number: 028 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 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
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) |
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| Devices Affected: |
| Implanted Nerve Stimulators |
|
| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE |
|
| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
|
| 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: |
| 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 |
|
| Michael Hoffman |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2570 |
| Silver Spring MD 20993 |
| 301/796-6476 |
| Email: michael.hoffman@fda.hhs.gov |
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| * 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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