Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Printed By

UsernamePublicRestriction

Adven To Submit Catheter Reuse PMA With Quality System In Disrepair

This article was originally published in The Gray Sheet

Executive Summary

Adven Medical's PMA submission for reprocessing Class III ablation catheters will cover multiple catheter models manufactured by a single original equipment manufacturer (OEM), according to the firm.

You may also be interested in...



Single-Use Device Reprocessor Adven Enters FDA Consent Decree

A consent decree between Adven Medical and FDA signals the agency's readiness to pursue enforcement action against reprocessors violating quality systems regulations

Single-Use Device Reprocessor Adven Enters FDA Consent Decree

A consent decree between Adven Medical and FDA signals the agency's readiness to pursue enforcement action against reprocessors violating quality systems regulations

FDA Faces Critical Choices On Reprocessing PMAs, IDEs Of March

Alliance Medical has stopped reprocessing Class III ablation catheters until the firm's PMA application for the device has been officially filed by FDA.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT014426

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel