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FDA suspends review of Datascope applications:

This article was originally published in Clinica

Executive Summary

The US FDA has suspended substantive review of marketing applications for products manufactured by Datascope's Patient Monitoring Divison and InterVascular pending assessment of the validity of data. The company informed the agency last year of certain regulatory issues discovered during the course of an internal audit (see Clinica No 642, p 12). The FDA's Application Integrity Policy does not apply to the company's Collagen Products Division, which manufactures VasoSeal. Approval of a PMA for VasoSeal was recommended for use in coronary angiography and angioplasty procedures by the FDA's Circulatory System Devices Panel on May 8th (see this issue page 1). The percutaneous device is used to achieve haemostasis after catheterisation procedures involving puncture of the femoral artery.

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