Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

FDA Petition on Anti Siphon CNS Shunts


Published on

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:

Published in: Health & Medicine
  • Be the first to comment

  • Be the first to like this