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

PMA (premarket approval) for Medtronic' second-generation implantable defibrillator:

This article was originally published in Clinica

Executive Summary

Medtronic has received premarket approval from the US FDA to market its GEM II DR (model 7273) dual chamber defibrillator. With a volume of 40cm3, this second generation product is 35% smaller than the GEM DR and is has an energy output of 30 joules. It combines the function of defibrillators and rate-responsive pacemakers, capable of discriminating between fast, life-threatening ventricular rhythms and harmless atrial arrhythmias.

You may also be interested in...



QUOTED. 20 February 2020. Steven Raman.

Less-invasive technologies to treat benign prostatic hyperplasia are fast becoming viable alternatives to medication and surgery. Here's what one researcher in the area, Steven Raman, had to say about the new options.

Novartis Logs Into India With Digital Innovation Hub

Novartis’s first digital innovation hub in Asia is launched in India, where the Swiss company hopes to ally with partners to deliver digital solutions for patients at scale.

Rx List Price Inflation Penalty Endorsed By US HHS Secretary

Senate Finance Committee’s approach to penalize companies for raising WAC list prices is not a ‘price control,’ but a reasonable approach to change the incentives that distort pricing in the supply chain, US HHS Secretary Alex Azar says.

Topics

UsernamePublicRestriction

Register

MT077438

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