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Click Here to Learn More on the FDA PMA Notice
Click Here to Learn More on the FDA PMA Notice

FDA PMA Notice for Defibrillators

The U.S. Food and Drug Administration (FDA) notified all AED and defibrillator manufacturers, distributors, owners, users, and prescribers that effective February 3, 2022, all accessories for non-FDA approved AEDs and professional defibrillators must no longer be supported by manufacturers. A unit is non-FDA approved if the manufacturer did not file for a premarket approval application (PMA) by the revised deadline of February 3, 2022. No entity can buy or sell accessories for non-FDA approved AEDs in the United States after February 3, 2022, effectively killing non-approved AEDs and defibrillators.

In accordance with FDA requirements, accessories (Including batteries, cables, pads, and parts) and service will no longer be available for these devices after February 3, 2022. MARS will continue to support these legacy units as accessory availability allows, until February 3, 2022.

Given the importance of these devices in emergency situations, the FDA recommends you continue to keep your AED available for use until you receive an FDA-approved AED/Defib.

Click Here to View the FDA PMA Letter

Which units does this affect?

This regulation will impact the following defibrillators and AEDs. In accordance with FDA requirements, accessories (including batteries, cables, pads, and parts) and service will no longer be available for these devices after February 3, 2022.

MARS will continue to support these legacy units as accessory availability allows, until February 3, 2022.

List of Non-Compliant Devices (Does not include all):

  • Welch Allyn AED 10

  • Cardiac Science 9200

  • Heartsine 300P

  • HP Codemaster

  • HP Codemaster XL

  • Philips FR2/FR2+

  • Philips Forerunner

  • Physio-Control Lifepak 9p

  • Physio-Control Lifepak 12

  • Physio-Control Lifepak 20

  • Physio-Control Lifepak 500

  • Philips Heartstart XL

  • Philips Heartstart MRx

  • Zoll M Series Defibrillator

  • Zoll E Series Defibrillator

  • Zoll PM2000

To view a full list of compliant devices click here.

What should you do if your AED/Defib is out of compliance?

Upgrade to a new or recertified AED/defibrillator that satisfies compliance regulations. Call our customer service line at 877-897-6277 and speak with our sales team so that we can help you transition to the best AED for your situation, giving you the lowest cost-of-ownership over the long term.

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