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: Powerheart G5 AED
• Generic Name: Automated external defibrillators (non-wearable)
• Regulation Number: 870.5310
• Applicant: ZOLL Medical Corporation; 269 Mill Rd.; Chelsmford, MA 01824
• PMA Number: P160033
• Supplement Number: S009
• Date Received: 03/10/2023
• Decision Date: 03/23/2023
• Product Code: MKJ
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Additional of a conformal coating to portions of the printed circuit board.