# P200028: DiamondTemp Ablation System

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Jan 28, 2021 after 227 days
- Product code: OAE (Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation)
- Device class: 3
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 22, 2021 · Class II · Z-1320-2021: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. Thi
- Feb 22, 2021 · Class II · Z-1322-2021: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. Thi
- Feb 22, 2021 · Class II · Z-1318-2021: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. Thi
- Feb 22, 2021 · Class II · Z-1317-2021: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. Thi
- Feb 22, 2021 · Class II · Z-1319-2021: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. Thi
- Feb 22, 2021 · Class II · Z-1321-2021: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. Thi

Source page: https://510kreport.com/device/P200028
Methodology: https://510kreport.com/methodology