FDA Accepts Imricor PMA Manufacturing Module

Key points

• FDA has completed its evaluation and accepted Imricor's PMA manufacturing module
• Module covers design, manufacturing, and quality processes for seven products
• Closure of the module is a significant milestone in the FDA review process

Full summary

Imricor Medical Systems, Inc. announced that the FDA has completed its evaluation and accepted the manufacturing module of the company's Premarket Approval (PMA) submission. This module, which is now closed, covers the design, manufacturing, and quality processes for seven products, including the Vision-MR Ablation Catheter and the RF-5000 Ablation Generator and Pump. The closure of this module is a significant milestone in the company's modular review process with the FDA, which involves submitting and reviewing different aspects of the products serially. The company is now awaiting the FDA's pre-approval inspection of its manufacturing sites before final PMA approval.