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Intensia VR 124

by Microport Crm SRL

Intensia VR 124 is a Class III device made by Microport Crm SRL, approved under FDA PMA P980049 on 15 Sep 1999 and listed in FDA GUDID since 20 Feb 2015 (UDI-DI 08031527012834), active as of 23 Oct 2026. 4 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

4 closed

Documents

PMA P980049

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 Number08031527012834 UDI-DI Date20 Feb 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP980049 Date15 Sep 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P980049 decided 15 Sep 1999 Active
  • FDA GUDID UDI-DI 08031527012834 listed 20 Feb 2015 Listed

Recalls

4 recalls · FDA

    • Terminated Z-3232-2017 FDA Class II initiated 24 Jul 2017

    There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac ResynchronizationTherapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.

  • 3 recalls, same reason

    • Terminated Z-3231-2017 FDA Class II initiated 24 Jul 2017
    • Terminated Z-3229-2017 FDA Class II initiated 24 Jul 2017
    • Terminated Z-3228-2017 FDA Class II initiated 24 Jul 2017

    There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.

Timeline

6 dated events

  1. Approved FDA PMA P980049
  2. Listed FDA GUDID 08031527012834
  3. Recall initiated FDA recalls Z-3232-2017
  4. Recall initiated FDA recalls Z-3231-2017
  5. Recall initiated FDA recalls Z-3229-2017
  6. Recall initiated FDA recalls Z-3228-2017

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Intensia
Generic name
Single-chamber implantable defibrillator
Model / reference
VR 124
Primary DI / UDI-DI
08031527012834
PMA number
FDA product code
MRM
GMDN term
Single-chamber implantable defibrillator
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Single-chamber implantable defibrillator

Cleared under the same submission (P980049)

and 8 more cleared under P980049

Similar devices

Other devices filed under FDA product code MRM (DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER).

Other devices from Microport Crm SRL

See all devices from Microport Crm SRL →

Properties

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