# P030035: Anthem and Frontier II CRT-P'S

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: May 13, 2004 after 258 days
- Product code: NKE (Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P))
- Device class: 3
- Recalls of this device: 5 (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

Source page: https://510kreport.com/device/P030035
Methodology: https://510kreport.com/methodology