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Alliance's Paragon Buy Consolidates EP Catheter Reprocessing Position

This article was originally published in The Gray Sheet

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Executive Summary

Alliance Medical is hoping to build on the ongoing transition to out-of-hospital medical device reprocessing with the acquisition of Paragon Healthcare in an all-cash deal.

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Alliance Expecting 510(k) Clearance For Class II SUDs; Catheter PMA Is Shaky

Alliance Medical's premarket approval application for reprocessing single-use ablation catheters is not approvable unless the firm obtains certain agreements with original equipment manufacturers (OEMs), FDA says.

Alliance Expecting 510(k) Clearance For Class II SUDs; Catheter PMA Is Shaky

Alliance Medical's premarket approval application for reprocessing single-use ablation catheters is not approvable unless the firm obtains certain agreements with original equipment manufacturers (OEMs), FDA says.

Paragon Facility Shut-Down Bears On FDA Talks With Reprocessor

Alliance Medical plans to meet with FDA to determine the appropriate response to a warning letter citing quality system regulation (QSR) deviations at Paragon Healthcare Corp.' s Spartanburg, South Carolina reprocessing facility.
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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