# P880086: Accent, Identity, Verity, Victory and Zephyr Pacemakers

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: Aug 21, 1989 after 279 days
- Product code: DXY (Implantable Pacemaker Pulse-Generator)
- Device class: 3
- Regulation: 21 CFR 870.3610
- Recalls of this device: 9 (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, 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.
- Sep 23, 2011 · Not classified · Z-0429-2012: St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements.These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic.
- Sep 23, 2011 · Not classified · Z-0430-2012: St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic
- Oct 6, 2006 · Not classified · Z-0296-2007: St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltag
- Oct 6, 2006 · Not classified · Z-0297-2007: St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltag
- Oct 6, 2006 · Not classified · Z-0298-2007: St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltag
- Jul 31, 2003 · Not classified · Z-0052-04: Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shor

Source page: https://510kreport.com/device/P880086
Methodology: https://510kreport.com/methodology