ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters

FDA premarket approval P200004 · decided 2021-09-26

Approval details

PMA number

P200004

Trade name

ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters

Generic name

Automated external defibrillators (non-wearable)

Applicant

Conmed Corporation

Date received

2020-01-31

Decision date

2021-09-26

Days to decision

604 days

Decision code

APPR

Product code

MKJ

Advisory committee

Cardiovascular

Expedited review

No

Location

Utica, NY

Statement

Approval for an Adult/Child 2001(radiotransparent), 2516(radiotranslucent):The ConMed PadPro radiotransparent and radiotranslucent external multifunction electrodes (MFEs). The device is indicated for use by trained medical professionals in medical facilities or medical transport environments to deliver energy for defibrillation, cardioversion, external pacing, and ECG monitoring applications. The MFE is a non-sterile, disposable device for single patient use only. The electrodes provide the con

510(k) clearances by this applicant