Download MSD 1015 - Docket Alarm

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user manual that is included with the product when the product is shipped. The
attached Work Order is for a NIM-Response product built in May 2000 and has a
Lot No. 19727500. The first and last page of the manual attached to the Work
Order confirms that the manual shipped with the product was the same User Guide
as Attachment A. The date stamped at the bottom of the Work Order indicates that
the NIM-Response product with this particular User Guide was built and ready for
shipment on May 26, 2000.
6.
I attach as Attachment C to this Declaration, a Sales Record for the NIM-
Response product for May 26, 2000. I note that the Lot No. is the same as that of
the Work Order above, Lot No.l9727500. This Sales Record confirms that on
May 26, 2000, the product and the accompanying User Guide was shipped to
customers.
7.
I have also attached a copy of the Work Order History from 2000-2001 for
the NIM-Response product as Attachment D to this Declaration. The Work Order
History shows that the NIM-Response product was continuously built and shipped
(with accompanying manual) throughout 2000-2001. At least as early as May 26,
2000, the manual shipped with the product was the User Guide.
8.
Thus, based on my review of the User Guide, Work Order, Sales Record,
and Work Order History, the User Guide was provided to customers, outside of
Medtronic, Inc., who bought the corresponding product, at least as early as May
26, 2000. Those customers included hospitals and clinics in the United States and
other countries. Medtronic, Inc. did not restrict the customers’ use or
dissemination of the User Guide.
9.
I hereby declare that all statements made herein of my own knowledge are
true and that all statements made on information and belief are believed to be true;
and further that these statements were made with the knowledge that willful false
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