Medtech Insight is part 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

In Brief: Perclose

This article was originally published in The Gray Sheet

Executive Summary

Perclose: Firm's Prostar 9 Fr and 11 Fr percutaneous vascular surgical systems will be reviewed under the premarket approval application process. Menlo Park, California-based Perclose, which submitted a 510(k) in July for the suture-based products, acknowledged at the time of its submission that there was "no assurance" its devices would ultimately be cleared via 510(k). The PMA will include the same data submitted with the 510(k) -- from a 500-patient, randomized, multicenter study comparing Prostar use to mechanical compression. "Based on a preliminary conversation, the FDA also indicated that it will review the PMA application, when filed, on an expedited basis," Perclose says...

You may also be interested in...



EWG Study Suggests More Than One In 10 Talc-Based Cosmetics Contain Asbestos

The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.

US FDA Reaffirms Commitment To Resuming Domestic Inspections As Industry Frustration Grows

Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.

‘Most Favored Nation’ Pricing Data May Be Long-Term Impact Of Last-Minute Rule

Rushed final rule seeking to impose draconian cuts on drug reimbursement rates in the Medicare Part B program is certain to face legal and political obstacles. But the data included on international price benchmarks will still have an impact.

UsernamePublicRestriction

Register

OM006145

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