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

Telectronics replacements for withdrawn Encor/Accufix pacer leads pending at FDA.

This article was originally published in The Gray Sheet

Executive Summary

TELECTRONICS REPLACEMENTS FOR ENCOR/ACCUFIX PACER LEADS are undergoing premarket review by FDA, the firm states. Two Maxim passive fixation (non-steroidal) atrial leads - one unipolar and one bipolar -- have been under 510(k) review by the agency since the applications were submitted in the first quarter, Telectronics says. A 510(k) also is pending for the firm's Secure active fixation (non-steroidal), bipolar, ventricular lead.

You may also be interested in...



New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

Connected Strategies Are Vital For Medtechs In The Consumer-Led 2020s

Discussions on the shape of health care have moved from “reimagining” to the next stage: building and executing on the vision. That is the thrust of EY’s NextWave Report: New Horizons 2019. Additionally, for medtechs seeking business continuum, “duality” is now a preoccupying thought.

ESG In 2020: Not A Tick-Box Exercise But A Strategic Opportunity

The idea that public corporations have obligations that extend beyond the fiduciary responsibility to shareholders will be the dominant measure of responsible business behavior in the coming decade. Uncertainty about the extent of these commitments – commonly referenced as the environmental, social and governance (ESG) agenda – has produced equally variable responses from companies in the health care business.

UsernamePublicRestriction

Register

MT006448

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