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Nucleus P1257243

by Cochlear

Nucleus P1257243 is a Class III device made by Cochlear, approved under FDA PMA P970051 on 25 Jun 1998 and listed in FDA GUDID since 13 Sep 2018 (UDI-DI 09321502043205), 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 P970051

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 Number09321502043205 UDI-DI Date13 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP970051 Date25 Jun 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P970051 decided 25 Jun 1998 Active
  • FDA GUDID UDI-DI 09321502043205 listed 13 Sep 2018 Listed

Recalls

3 recalls · FDA

    • Terminated Z-2155-2015 FDA Class II initiated 5 Jun 2015

    Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.

    • Terminated Z-0003-2012 FDA Unclassified (pre-2012) initiated 16 Sep 2011

    Cochlear implant may shut down and cease to function.

    • Terminated Z-0119-2010 FDA Unclassified (pre-2012) initiated 30 Sep 2009

    Cochlear implant device component was mis-labeled.

Timeline

5 dated events

  1. Approved FDA PMA P970051
  2. Recall initiated FDA recalls Z-0119-2010
  3. Recall initiated FDA recalls Z-0003-2012
  4. Recall initiated FDA recalls Z-2155-2015
  5. Listed FDA GUDID 09321502043205

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Nucleus
Generic name
Audiometric/hearing device software
Model / Ref / Catalog
P1257243
Primary DI / UDI-DI
09321502043205
PMA number
FDA product code
MCM
GMDN term
Audiometric/hearing device software
Device class
Class III
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Audiometric/hearing device software

Cleared under the same submission (P970051)

and 8 more cleared under P970051

Similar devices

Other devices filed under FDA product code MCM (IMPLANT, COCHLEAR).

Other devices from Cochlear

See all devices from Cochlear →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)