ConMed PadPro Multifunction Electrodes

FDA Premarket Approval P200004 S001

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.

Pre-market Approval Supplement Details

DeviceConMed PadPro Multifunction Electrodes
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantConMed Corporation525 French Roadutica, NY 13502 PMA NumberP200004 Supplement NumberS001 Date Received05/19/2022 Decision Date06/16/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-19
Decision Date2022-06-16
PMAP200004
SupplementS001
Product CodeMKJ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressConMed Corporation
525 French Road
utica, NY 13502 PMA NumberP200004 Supplement NumberS001 Date Received05/19/2022 Decision Date06/16/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Change The Test Site For Sterilization Test Samples And Remove Redundant Post-sterile Finished Device Testing

Supplemental Filings

Supplement NumberDateSupplement Type
P200004Original Filing
S001 2022-05-19 30-day Notice

NIH GUDID Devices

Device IDPMASupp
20845854050887 P200004 000
20845854050870 P200004 000
20653405986628 P200004 000
20653405081989 P200004 000

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