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Sjm™ 1776

by Irvine Biomedical, Inc.

Sjm™ 1776 (IBI-85776) is a Class III device made by Irvine Biomedical, Inc., approved under FDA PMA P060019 on 16 Mar 2007 and listed in FDA GUDID since 31 Oct 2014 (UDI-DI 05414734309059), active as of 23 Oct 2026. One FDA recall is 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

1 closed

Documents

PMA P060019

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 Number05414734309059 UDI-DI Date31 Oct 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP060019 Date16 Mar 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P060019 decided 16 Mar 2007 Active
  • FDA GUDID UDI-DI 05414734309059 listed 31 Oct 2014 Listed

Recalls

1 recall · FDA

    • Terminated Z-1032-2012 FDA Not yet classified initiated 5 Jan 2012

    Two St Jude Medical 1500T9 RF Generator units were distributed to customers while still under FDA review as part of a PMA supplement to the approved PMA applications.

Timeline

3 dated events

  1. Approved FDA PMA P060019
  2. Recall initiated FDA recalls Z-1032-2012
  3. Listed FDA GUDID 05414734309059

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  • Withdrawn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
Electrical-only medical device connection cable, reusable
Model / Ref / Catalog
1776, IBI-85776
Primary DI / UDI-DI
05414734309059
PMA number
FDA product code
OAD
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class III
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Electrical-only medical device connection cable, reusable

Cleared under the same submission (P060019)

and 8 more cleared under P060019

Similar devices in this category

Other devices filed under Electrical-only medical device connection cable, reusable.

Other devices from Irvine Biomedical, Inc.(Ibi)

See all devices from Irvine Biomedical, Inc.(Ibi) →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)