# Sjm™ DS0A001

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/sjm-ds0a001>
- Manufacturer: [St. Jude Medical, Inc.](https://devicerts.com/manufacturers/st-jude-medical-inc) (United States, FDA PMA applicant)
- Name in the registry: SJM™ DS0A001
- Device class: Class III (US FDA)
- FDA product code: LWS
- GMDN: Implantable electrical stimulation lead suture sleeve (46225)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 05414734504973 · listed 2017-04-10 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA PMA · United States · P950022 · decision 1996-05-10 · decision APPR · status: Active · from GUDID

## Recalls

- Z-0660-2016 · Class I · terminated · initiated 2015-11-03: Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
- Z-0458-2012 ·  · terminated · initiated 2011-11-28: 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 Leads with specific emphasis on externalized conductors.
- Z-0457-2012 ·  · terminated · initiated 2011-11-28: 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 externalized conductors.

## Identity

- Trade name: SJM™ [FDA GUDID (AccessGUDID)]
- Generic name: Implantable electrical stimulation lead suture sleeve [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: DS0A001 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 05414734504973 [FDA GUDID (AccessGUDID)]
- PMA number: P950022 [FDA GUDID (AccessGUDID)]
- FDA product code: LWS [FDA GUDID (AccessGUDID)]
- GMDN term: Implantable electrical stimulation lead suture sleeve (46225) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class III [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Dimensions & Sizes

- Size: Catheter Gauge — 7 French [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Implantable: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Sjm™ DS0A001, St. Jude Medical, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/sjm-ds0a001 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/sjm-ds0a001.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/sjm-ds0a001
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.