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

HEALTHDYNE'S TRANQUILITY MP*R CPAP SYSTEM CHANGES REQUIRE 510(k) CLEARANCE

This article was originally published in The Gray Sheet

Executive Summary

HEALTHDYNE'S TRANQUILITY MP*R CPAP SYSTEM CHANGES REQUIRE 510(k) CLEARANCE, FDA says in a June 29 warning letter. The agency says that its review of promotional and labeling material for the continuous positive airway pressure system revealed "significant changes affecting the safety and efficacy of the device." FDA points out several significant changes that were made to the device since the original 510(k) was cleared in 1989. The modifications include, "but are not limited to, addition of microprocessor control, pressure control system changes, external phone line control, and the addition of a remote control." The agency also cites an addition to labeling, not cleared under the original 510(k), which states that the monitor "represents a significant advance in the technology used in the treatment of obstructive sleep apnea syndrome." After discussions with the agency, Healthdyne says it submitted a response to the warning letter the week of July 12. Healthdyne believes that the warning letter was the result of a "misunderstanding" between the company and FDA and that a new 510(k) will not be necessary for the device. According to the company, not all changes cited by FDA were actually made. For example, the firm says that a remote control was not added to the device. Healthdyne says that four minor modifications have been made to the device since 510(k) clearance, none of which the firm feels warrant a new 510(k). The modifications included: a change in the location of the pressure gauge ** addition of an on/off switch for user convenience ** modification of the overall shape of the device ** and a name change from Tranquility to Tranquility MPr for marketing purposes.

You may also be interested in...



What Lies Ahead: COVID-19 Vaccination Challenges

The director of adult immunizations at Johns Hopkins International Vaccine Access Center talks to Scrip about undertaking a massive COVID-19 vaccination effort in the US.

P&G: Sales Growth Strongest When Rising Tide Floats All Competitors Across All Categories

P&G’s oral care business drove 35% of total category market growth in the firm’s fiscal 2020 and exemplifies its growth strategy for all segments – grow entire categories rather than take competitors’ market share, says CFO Jon Moeller.

COVID-19 Vaccine 'Brexit Bonus' A Myth

The Pink Sheet explains the procedures underpinning the UK’s emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine.

UsernamePublicRestriction

Register

OM006664

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