# P150033: Medtronic Micra Transcatheter Pacemaker System

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Apr 6, 2016 after 202 days
- Product code: PNJ (Leadless Pacemaker)
- Device class: 3
- Regulation: 21 CFR 870.3610
- Recalls of this device: 4 (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
- Jun 17, 2025 · Class II · Z-2128-2025: A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon inter
- Jun 17, 2025 · Class II · Z-2127-2025: A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon inter
- Aug 6, 2019 · Class II · Z-2492-2019: Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the
- Aug 6, 2019 · Class II · Z-2493-2019: Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the

Source page: https://510kreport.com/device/P150033
Methodology: https://510kreport.com/methodology