# P960016: Livewire (R) Cardiac Ablation System

- Pathway: PMA
- Applicant: St Jude Medical
- Decided: May 4, 1999 after 1,082 days
- Product code: LPB (Cardiac Ablation Percutaneous Catheter)
- Device class: 3
- Recalls of this device: 1 (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 5, 2008 · Not classified · Z-2313-2008: St. Jude Medical has initiated a recall of one lot of Livewire TC" Ablation Catheter. The product was mis-labelled as having an 8 mm tip instead of 4 mm tip. This could potentially result in elevated 

Source page: https://510kreport.com/device/P960016
Methodology: https://510kreport.com/methodology