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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 AED 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 NumberS001
Date Received04/18/2025
Decision Date11/12/2025
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for an update to a manufacturing step of an intermediate component of the radiotransparent defibrillator pads
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