FDA Dispute Resolution Panel To Review CardioGenesis PMR Data In August
This article was originally published in The Gray Sheet
Executive Summary
CardioGenesis will rely on data previously reviewed by FDA in seeking to overturn an initial "not approvable" determination by the agency for its PMR percutaneous myocardial revascularization system
You may also be interested in...
PMR back to the drawing board
CardioGenesis will not seek an FDA Medical Devices Dispute Resolution Panel review, following an unapprovable determination by the agency on the firm's PMA supplement for percutaneous myocardial revascularization (PMR). Further clinical work to gain approval will be considered during a future meeting with FDA, the company says. CardioGenesis cancelled an August 2003 dispute resolution panel review in an attempt to reconcile its clinical data directly with the agency (1"The Gray Sheet" June 2, 2003, p. 6). While CardioGenesis has not completely abandoned the notion of a future dispute panel review, the firm will focus on securing approval in Europe, Canada and Australia. CardioGenesis shares plummeted 29% on the news, closing at $0.74 on March 25...
FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility
The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.