# P950022: TVL (TM) Lead System

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: May 10, 1996 after 315 days
- Product code: LWS (Implantable Cardioverter Defibrillator (Non-Crt))
- Device class: 3
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
1 of 6 devices 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.

## Most influential descendants
- K093858: Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A (2010), 1 descendant of its own
- K090163: Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078 (2009), 1 descendant of its own
- K191469: Biotronik Stylets (2019), 0 descendants of its own
- K101982: Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180 (2010), 0 descendants of its own
- K080924: Mond Rvot Stylet Models 4140, 4141, 4150, 4151 (2008), 0 descendants of its own

## Recalls of this device
- Nov 3, 2015 · Class I · Z-0660-2016: Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
- Nov 28, 2011 · Not classified · Z-0457-2012: St. Jude Medical has confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads with specific emphasis on 
- Nov 28, 2011 · Not classified · Z-0458-2012: The recall was initiated because St. Jude Medical has confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation

Source page: https://510kreport.com/device/P950022
Methodology: https://510kreport.com/methodology