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CDRH Dispute Resolution Panel Set To Meet For First Time In Years

This article was originally published in The Gray Sheet

Executive Summary

For the first time in over three years, the ombudsman of FDA's device center has referred a company to the Medical Device Dispute Resolution Panel

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Acorn Asks For More Help From Investors After FDA Panel Denies CorCap PMA

Acorn Cardiovascular says it will ask its current investors to fund a confirmatory trial of its CorCap Cardiac Support Device after an FDA advisory panel decided more research is needed before it could support premarket approval

Acorn Asks For More Help From Investors After FDA Panel Denies CorCap PMA

Acorn Cardiovascular says it will ask its current investors to fund a confirmatory trial of its CorCap Cardiac Support Device after an FDA advisory panel decided more research is needed before it could support premarket approval

CorCap controversy headed for panel

Acorn Cardiovascular's CorCap cardiac support device has the dubious distinction of being one of two devices referred to FDA's Medical Devices Dispute Resolution Panel in 2006 after three years of inactivity from the independent review body. The panel will convene Dec. 15 to review the science behind the company's PMA application for the polyester mesh wrap, intended to provide ventricular support in patients with symptomatic heart failure despite optimal medical management, Acorn's Oct. 17 release indicates. FDA's Circulatory System Devices Panel voted 9-4 against approval in June 2005 (1"The Gray Sheet" June 27, 2005, p. 3). Cardima's request for a hearing on its Revelation Tx ablation microcatheter system was granted in July (2"The Gray Sheet" July 24, 2006, p. 6)...

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