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Philips U.S. PMA Information

Philips is pleased to share with you the following list of AEDs and their associated accessories now have premarket approval (PMA) by the United States Food and Drug Administration (FDA).

Device

PMA Number

FDA PMA Approval Order Web Address

Philips HeartStart FR3 Defibrillator (Models 861388 and 861389)

P160028

HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

P160029

HeartStart FRx Defibrillator (Model 861304)

P180028

For more information on AED devices with PMA approval, please click here:

Philips previously communicated that the FDA imposed new requirements in February 2015 on manufacturers of automated external defibrillators (AEDs) and devices with an integrated AED mode. Under these new requirements, manufacturers must comply with the premarket approval (PMA) process instead of the previous 510(k) clearance process for these devices and their accessories, e.g., pad electrodes and batteries. Previously in September of 2019, the FDA clarified its position and informed all manufacturers that currently marketed accessories for use on AEDs and devices containing an AED mode, for which no PMA is filed (“Legacy AED Accessories”), could not be sold or delivered after February 3, 2021. This restriction on the sale and delivery of accessories does not prevent owners of MRx’s and other defibrillators that were legally sold under a 510(k) clearance from continuing to use their devices. 

 

In June 2020, FDA informed Philips that due to the COVID-19 pandemic, it will permit the distribution of Legacy AED Accessories for an additional year, i.e., until February 3, 2022. Therefore, the new end-of-life date for supplying HeartStart MRx pad electrodes, batteries and accessories in the United States has been extended to February 3, 2022. After this date, Philips will no longer be able to ship HeartStart MRx pad electrodes and batteries in the USA. The last day to place orders for MRx pad electrodes, batteries and accessories will be January 2, 2022. Philips intends to honor orders, as inventory allows, until February 2, 2022.

Your continued satisfaction with Philips AEDs and Monitor-Defibrillators is very important to us and we want to ensure your confidence in the reliability of our solutions.
 

What action should United States customers take?

  • Take inventory of your AEDs and monitor-defibrillators and check them against the FDA-approved devices list
  • If any of your devices are not included on the FDA-approved devices list, contact us for information about how you can transition to FDA-approved devices

No action is required for customers outside the United States

The PMA status for Philips end of production solutions is below:

Device

Status

HeartStart FR2/FR2+ AED

HeartStart FR2/FR2+ and associated accessories, with the exception of pads and batteries, have reached or will reach end-of-life/end-of-shipment dates in the United States before February 3, 2022. In the United States, orders for FR2/FR2+ pads and batteries can be placed until December 31, 2020, and orders will be fulfilled, as inventory allows, through February 3, 2022

HeartStart MRx monitor/defibrillator

In May 2017, Philips discontinued the HeartStart MRx Advanced Life Support (ALS) monitor-defibrillator. The FDA recently provided an update on premarket approval (PMA) policy guidelines for Automated External Defibrillators (AEDs). Based on these updated guidelines, in the United States Philips will continue to offer HeartStart MRx batteries, pads, and hands-free cables, only until February 3, 2022. Orders for MRx batteries, pads, and hands-free cables must be placed by December 31, 2020, in the United States only. These items can continue to ship outside the United States beyond this date.

HeartStart XL defibrillator/monitor

Philips HeartStart XL defibrillator/monitors’ related accessories and disposables have reached or will reach their end-of-life/end-of-shipment dates before February 3, 2022, in the United States.

HeartStart XL+ defibrillator/monitor

Philips HeartStart XL+ defibrillator/monitors’ battery, pads and hands-free cable have reached or will reach their end-of-life/end-of-shipment dates before February 3, 2022, in the United States only. For customers outside of the United States, battery, pads and hands-free cable will continue to be shipped after this date.

FAQ

 

Q: What is PMA?

 

A: Premarket approval (PMA) is the most stringent type of premarket submission required by U.S. Food and Drug Administration (FDA). PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).
 

In February 2015, the FDA issued a new order requiring that manufacturers submit PMAs for new and existing AEDs and accessories.

 

Q: The HeartStart MRx, XL/XL+, and FR2/FR2+ are not listed as a PMA approved devices on the FDA website. Are these devices not FDA approved?

 

A: The MRx, XL/XL+, and FR2/FR2+ are not PMA approved. These devices in the United States that were legally sold under a 510(k) clearance can continue to be used by their owners. Philips will continue to offer batteries, pads, and hands-free cables, only until February 3, 2022, in the United States.

 

Q: Must the MRx, XL/XL+, and FR2/FR2+ be removed from customer sites in the United States?

 

A: HeartStart MRx, XL/XL+, and FR2/FR2+ devices installed at customer sites may remain in service.

Please refer to the letters for more details regarding PMA status for Philips end of production solutions.

Please contact your Philips representative for assistance or additional information.

Additional information

For more information regarding the Philips Defibrillator Consent Decree, please click here.

Current Product Status Letters:

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