NeuroCybernetic Prostheses Software Class II


Model 250 NeuroCybernetic Prostheses (NCP) Programming Software Versions

a) 4/1;

b) 4.4, implanted autonomic nerve stimulator for he treatment of


The label insert sheets were printed with the incorrect lot number.


Lot numbers a) 23952C; b) 26023C, 27137C, 27735C.

Recall #Z-570/571-0.


Cyberonics, Inc., Inc., Houston, Texas.


Manufacturer, by telephone and letter on August October 6, 1999. Firm-
initiated field correction complete.


a) Canada; b) Belgium and Europe.


a) 1 unit of lot number 23952C; b) 10 units of lot number, 26023C, 10
units of lot 27137C and 50 units of lot 27735C were distributed.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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