# P200046: Harmony™ TPV System

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Mar 26, 2021 after 128 days
- Product code: NPV (Pulmonary Valve Prosthesis Percutaneously Delivered)
- Device class: f
- Recalls of this device: 2 (2 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.
1 of 1 device in its family (counting itself) has 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
- May 22, 2026 · Class I · Z-2624-2026: Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical con
- Mar 2, 2022 · Class I · Z-0927-2022: There is potential for the capsule bond to break during the procedure.

Source page: https://510kreport.com/device/P200046
Methodology: https://510kreport.com/methodology