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This is the Food and Drug Administration's Sept. 1998 ruling on my citizen's petition on safety issues with CNS anti-siphon shunts - which FDA withheld from the Federal Register. In follow up, I designed an mHealth solution for a PDA I named the DiaCeph Test - to eval shunt malfunction and outcomes. This could be a mobile app today.
My petition was filed in Nov. 1996. It led to the 1999 STAMP Conference in Washington D.C., where I was NOT invited to appear on the panel & discuss these challenges, which I suspect was bc my petition criticized a Medtronic division's device. Medtronic since integrated this same anti siphon technology into its programmable Strata shunts, where since 2017 the FDA mandated warnings per their 1998 ruling have been removed.
I no longer have 949-642-4592 telephone number. Please reach me at contact[at]dollecommunications[dot]com
For more on my petition and DiaCeph mHealth technology, see this blog: