Category: Cook Medical
Here's a look at some of the top regulatory stories for medical device companies this week: Debate heats up during FDA meeting over uterine surgical device and cancer risk; Merit Medical wins China OK for Aero device; Back in the USA: Cook Medical's Evolution lead extraction device returns; FDA flags Zynex Medical over chronic pain devices; FDA offers new guidance on 510(k) risk/benefit review
Cook Medical says its Evolution cardiac lead extraction device line is back on the U.S. market after a 2-month hiatus prompted by an FDA warning.
Cook Medical said today that it's Evolution RL and Evolution Shortie RL cardiac lead extraction devices are back on the U.S. market after a 2-month suspension prompted by an FDA warning issued last April.
Here's a look at some of the top regulatory stories for medical device companies this week: Senate Republicans want answers from FDA commish Hamburg on draft guidances; Medtech regulation: FDA releases April 2014 510(k) decisions; Prosthetic arm that translates muscle signals into action wins FDA approval; FDA warns Cook Medical on unapproved changes to Evolution lead extractor; FDA: Foreign medtech firms receive excess manufacturing violations.
The FDA sends a warning letter to Cook Medical, accusing the company of making unapproved changes to its Evolution RL lead extraction device.
The FDA last month accused Cook Medical of selling an unapproved device in the U.S., saying changes made to Cook Vascular's Evolution RL cardiac lead extraction device require the medical device company to file a new clearance application with the watchdog agency.
The Philadelphia Court of Common Pleas establishes a mass tort for all pelvic mesh lawsuits filed in its jurisdiction.
A Pennsylvania state judge ordered the creation of a mass tort this week to collect product liability lawsuits filed over pelvic mesh products against some of the largest names in medical devices.
Judge Arnold New, director of the Complex Litigation Center at the Philadelphia Court of Common Pleas, ordered Feb. 11 that "all currently filed pelvic mesh matters shall be transferred to the Complex Litigation Center Pelvic Mesh Mass Tort Program" for coordination, according to court documents.
A federal judge orders the selection of 200 lawsuits for discovery proceedings in the multi-district litigation over C.R. Bard's Avaulta pelvic mesh products.
The mass tort against C.R. Bard (NYSE:BCR) is about to generate an avalanche of paper after a federal judge ordered the plaintiffs and Bard to choose some 200 lawsuits for discovery.
Cook Medical begins a clinical trial of its Evolution esophageal stent.
Cook Medical said it started a multi-center clinical trial of its Evolution esophageal stent.
The study is designed to test the possibility of removing the self-expanding, covered metal stent after treatment of malignant and benign strictures including strictures, fistulas or perforations.