Imricor Medical Systems Receives FDA Acceptance for PMA Manufacturing Module

Imricor Medical Systems announced that the U.S. Food and Drug Administration (FDA) has completed its review and accepted the manufacturing module of the company's Premarket Approval (PMA) submission. This module covers the design, manufacturing, and quality control processes for seven products, including the Vision-MR4 Ablation Catheter. This marks a significant milestone in the modular PMA process, with a pre-approval inspection of manufacturing facilities expected before final PMA approval.