NeuroCybernetic Prostheses Software Class II

PRODUCT

Model 250 NeuroCybernetic Prostheses (NCP) Programming Software Versions

a) 4/1;

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

REASON

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

CODE

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

Recall #Z-570/571-0.

MANFACTURER

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

RECALLED BY

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

DISTRIBUTION

a) Canada; b) Belgium and Europe.

QUANTITY

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.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.