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.” *
Stryker's planned discontinuations
September 2019 – Stryker will continue to honor existing service contracts, as parts availability allows, until no later than June 30, 2020.
Accessories that are part of some service plans, including LIFEPAK 500 and LIFEPAK 12 batteries, will no longer be available as part of the service offering past February 3, 2020.
LIFEPAK 20 devices which require battery replacement as part of its service will be available as supplies last, but no later than December 31, 2020.
Based on the extension from FDA, other accessories such as pad electrodes will continue to be available and will no longer be marketed after February 3, 2021.
For more information on this product discontinuation and how we are complying with the latest FDA final order, please review the following.
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.