Vivasure Submits PMA For Vascular Closure System To FDA - Data Intelligence
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Vivasure Medical submits premarket approval to FDA for PerQseal Elite closure system - Interventional News
Vivasure Medical has announced the submission of a premarket approval application to the US Food and Drug Administration (FDA) for its PerQseal Elite vascular closure system for arterial procedures. In a recent press release the company has stated that the submission builds upon the successful results of the PATCH study as well as positive clinical use in Europe, reinforcing the system’s potential safety and performance profile. In addition, the…
Vivasure Submits PMA For Vascular Closure System To FDA - Data Intelligence
The system is a fully absorbable, sutureless closure device for use after percutaneous cardiovascular procedures. Credit: Max Acronym / Shutterstock. Irish company Vivasure Medical has submitted an application seeking premarket approval (PMA) from the US Food and Drug Administration (FDA) for its PerQseal Elite vascular closure system intended for arterial procedures. This submission is supported by the outcomes of the PATCH study and the system…
Vivasure Medical submits premarket approval for PerQseal Elite vascular closure device - Cardiovascular News
PerQseal Vivasure Medical has announced the submission of a premarket approval (PMA) application to the US Food and Drug Administration (FDA) for its PerQseal Elite vascular closure system for arterial procedures. The submission builds upon the successful results of the PATCH study as well as positive clinical use in Europe, reinforcing the system’s potential safety and performance profile. In addition, the company received European CE mark appr…
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