PLC Backs Away From PMR; CardioGenesis Continues To Seek PMA Approval
This article was originally published in The Gray Sheet
Executive Summary
Heart laser manufacturers CardioGenesis and PLC Medical Systems are pursuing divergent approaches to product development in the wake of an unfavorable panel review for CardioGenesis' PMR percutaneous myocardial revascularization system.
You may also be interested in...
CardioGenesis’ PMR On Deck For FDA Dispute Resolution Panel Review
CardioGenesis is retaining Covington & Burling to help prepare for its upcoming dispute resolution panel. The regulatory law firm consulted Lifecore Biomedical in the only other MDDRP review
CardioGenesis’ PMR On Deck For FDA Dispute Resolution Panel Review
CardioGenesis is retaining Covington & Burling to help prepare for its upcoming dispute resolution panel. The regulatory law firm consulted Lifecore Biomedical in the only other MDDRP review
CardioGenesis Data From 900 Additional Patients May Push PMR Over Top
CardioGenesis is hoping that its PMR percutaneous myocardial revascularization system can be approved by early 2003 without a second panel review