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Sjm™ DS0A001

by St. Jude Medical, Inc.

Sjm DS0A001 is a medical device (FDA Class III; FDA product code LWS, Implantable cardioverter defibrillator (non-CRT)) made by St. Jude Medical, Inc., approved under FDA PMA P950022 on 10 May 1996 and listed in FDA GUDID since 10 Apr 2017 (UDI-DI 05414734504973), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

3 closed

Documents

PMA P950022

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05414734504973 UDI-DI Date10 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP950022 Date10 May 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P950022 decided 10 May 1996 Active
  • FDA GUDID UDI-DI 05414734504973 listed 10 Apr 2017 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0660-2016 FDA Class I initiated 3 Nov 2015

    Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.

    • Terminated Z-0458-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011

    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.

    • Terminated Z-0457-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011

    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.

Timeline

5 dated events

  1. Approved FDA PMA P950022
  2. Recall initiated FDA recalls Z-0458-2012
  3. Recall initiated FDA recalls Z-0457-2012
  4. Recall initiated FDA recalls Z-0660-2016
  5. Listed FDA GUDID 05414734504973

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
Sjm™
Generic name
Implantable electrical stimulation lead suture sleeve
Model / Ref / Catalog
DS0A001
Primary DI / UDI-DI
05414734504973
PMA number
FDA product code
LWS
GMDN term
Implantable electrical stimulation lead suture sleeve
Device class
Class III
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 7 French

Related devices

Category: Implantable electrical stimulation lead suture sleeve

Cleared under the same submission (P950022)

and 8 more cleared under P950022

Similar devices

Other devices filed under FDA product code LWS (Implantable cardioverter defibrillator (non-CRT)).

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)