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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceHeartSync Multifunction Disposable Single-Use Defibrillator Pads
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantGraphic Controls D.B.A. Vermed
400 Exchange St.
Buffalo, NY 14204
PMA NumberP200007
Supplement NumberS002
Date Received11/24/2025
Decision Date12/19/2025
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a modification of the primary packaging pouch for the HeartSync Multifunction Disposable Single-Use AED defibrillator pad, T100AC-Zoll-10, and T100-CS
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