Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: AED 3™
• Generic Name: Automated external defibrillators (non-wearable)
• Regulation Number: 870.5310
• Applicant: ZOLL Medical Corporation; 269 & 271 Mill Rd.; Chelsmford, MA 01824
• PMA Number: P160015
• Supplement Number: S025
• Date Received: 07/03/2025
• Decision Date: 12/18/2025
• Product Code: MKJ
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
approval for updates to the labeling to add post-approval study results.