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: ConMed PadPro Multifunction Electrodes
• Generic Name: Automated external defibrillators (non-wearable)
• Regulation Number: 870.5310
• Applicant: Conmed Corporation; 525 French Rd.; Utica, NY 13502
• PMA Number: P200004
• Supplement Number: S001
• Date Received: 05/19/2022
• Decision Date: 06/16/2022
• 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  
Change the test site for sterilization test samples and remove redundant post-sterile finished device testing.