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) |
| Applicant | ConMed 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 Received | 2022-05-19 |
| Decision Date | 2022-06-16 |
| PMA | P200004 |
| Supplement | S001 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ConMed 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200004 | Original Filing | |
| S001 | 2022-05-19 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 20845854050887 | P200004 | 000 |
| 20845854050870 | P200004 | 000 |
| 20653405986628 | P200004 | 000 |
| 20653405081989 | P200004 | 000 |