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Gastric pacer regulatory upgrade

This article was originally published in The Gray Sheet

Executive Summary

FDA rejects Gastroparesis & Dysmotilities Association's request that the agency convene its Gastroenterology & Urology Devices Panel to consider transferring approval of Medtronic's Enterra therapy from a humanitarian device exemption to a PMA by using current clinical data. Medtronic is conducting a clinical trial to support a full PMA in 2006. "There is no regulatory means of 'transferring' approval status," FDA explains in the November letter declining the advocacy group's Feb. 24 petition. GPDA had argued that many private insurance carriers are denying claims for the gastric neurostimulation implant because they mistakenly believe that HDE status is tantamount to calling Enterra "experimental" and therefore ineligible for coverage (1"The Gray Sheet" March 22, 2004, p. 17)...

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