# P140033: Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: Jan 31, 2017 after 769 days
- Product code: LWP (Implantable Pulse Generator, Pacemaker (Non-Crt))
- Device class: 3
- Recalls of this device: 5 (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
- Jun 17, 2022 · Class II · Z-1497-2022: The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and 
- Jun 17, 2022 · Class II · Z-1496-2022: The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and 
- Jun 17, 2022 · Class II · Z-1495-2022: There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
- Mar 15, 2021 · Class I · Z-1530-2021: Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture 
- Mar 15, 2021 · Class I · Z-1531-2021: Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture 

Source page: https://510kreport.com/device/P140033
Methodology: https://510kreport.com/methodology