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FDA event timeline

April 2019 – The FDA communicated with all AED manufacturers regarding the final order requiring premarket approval (PMA) applications for new and existing AEDs and necessary AED accessories by February 3, 2020:

“In April 2019, the FDA sent letters to all AED manufacturers, who did not submit a premarket approval (PMA) application for their AEDs as required by the final order, reminding them they can no longer market their AED; the letters also informed the manufactures that necessary AED accessories may not be marketed after February 3, 2020, if a PMA is not filed.”*

September 2019 – In order to allow customers adequate time to transition to PMA approved AEDs, the FDA updated the deadline for marketing AED accessories to no later than February 3, 2021.

“FDA does not intend to enforce compliance with the February 3, 2020, deadline for necessary AED accessories for one year in order to allow health care facilities time to transition to FDA-approved AEDs.” *

September 2019 – In order to allow customers adequate time to transition to PMA approved AEDs, the FDA updated the deadline for marketing AED accessories to no later than February 3, 2021.

“FDA does not intend to enforce compliance with the February 3, 2020, deadline for necessary AED accessories for one year in order to allow health care facilities time to transition to FDA-approved AEDs.”*

October 2020 – Due to hardship related to the COVID-19 pandemic the FDA updated their website with a deadline extension for marketing AED accessories to no later than February 3, 2022.

*https://www.fda.gov/medical-devices/cardiovascular-devices/automated-external-defibrillators-aeds

 

Stryker's planned discontinuations

Updated October 2020 – Based on previous guidance from FDA, Stryker had taken steps to discontinue affected devices and accessories. These plans will continue and include the following dates.

LIFEPAK 20 batteries and service will be available as supplies last, but no later than December 31, 2020.

Other LIFEPAK accessories such as pad electrodes will continue to be available and will no longer be marketed after February 3, 2022.

Accessories that are part of some service plans, including LIFEPAK 500 and LIFEPAK 12 batteries, were discontinued as of February 3, 2020

Stryker honored existing service contracts for LIFEPAK 12 through June 30, 2020.

For the discontinued HeartSine AEDs, the date after which the Pad-Pak will not be available for use with the HeartSine SAM 300 or SAM 300P, and the Pediatric-Pak will not be available for use with the HeartSine SAM 300P has been extended from February 3, 2021 to February 3, 2022.

Additional resources

For more information on this product discontinuation and how we are complying with the latest FDA final order, please review the following.

FDA | Automated External Defibrillator (AEDs) Website

Thank you for your business and continued partnership. We are committed to providing high-quality, clinically relevant products so that you can be confident in the care you are providing to your communities.

Please contact your local Stryker sales representative or authorized distributor to discuss trade-up and flexible financing options to support you during this transition. For more information, review the additional resources above.