Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Perclose must file premarket approval (PMA) for vessel closure devices:

This article was originally published in Clinica

Executive Summary

Perclose has been told it will have to file a PMA for its Prostar vascular closure devices, but that it will receive an expedited review. The company had previously submitted a 510(k) premarket clearance notification based on a 500-patient multicentre trial of the 9- and 11-F Prostar devices, which are used to close arteries catheterised during angioplasty. Perclose says it will use the same data for the PMA.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT089384

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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