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Percepta Bipolar CRT-P

by Medtronic, Inc. PMA

Active United States

PMA P010015

Overview

The Percepta Bipolar CRT-P is an implantable pulse generator designed for cardiac resynchronization therapy. It is indicated for the reduction of symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤35% and a QRS duration ≥130 ms.

This device is supplied as part of the Medtronic InSync biventricular pacing system, which includes the Model 8040 pulse generator, Model 9980 programmer software, and Attain LV Model 2187 and Attain CS Model 2188 leads. The pulse generator and leads are implantable and intended for long-term use. Regulatory authorization is via FDA PMA (P010015).

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

Recall ongoing on a related submission. 5 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP010015 Date28 Aug 2001ApprovedStatusActive

Coverage

1 jurisdiction

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

United States — FDA PMA Active

Recalls

10 recalls · 5 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2127-2025 FDA Class II initiated 17 Jun 2025 via P010015, on the same PMA
    • Ongoing Z-2128-2025 FDA Class II initiated 17 Jun 2025 via P010015, on the same PMA

    A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.

  • 3 recalls, same reason

    • Ongoing Z-2512-2020 FDA Class II initiated 4 Jun 2020 via P010015, on the same PMA
    • Ongoing Z-2511-2020 FDA Class II initiated 4 Jun 2020 via P010015, on the same PMA
    • Ongoing Z-2513-2020 FDA Class II initiated 4 Jun 2020 via P010015, on the same PMA

    There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

  • 4 recalls, same reason

    • Terminated Z-2412-2018 FDA Class II initiated 21 Jun 2018 via P010015, on the same PMA
    • Terminated Z-2414-2018 FDA Class II initiated 21 Jun 2018 via P010015, on the same PMA
    • Terminated Z-2415-2018 FDA Class II initiated 21 Jun 2018 via P010015, on the same PMA
    • Terminated Z-2413-2018 FDA Class II initiated 21 Jun 2018 via P010015, on the same PMA

    Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).

    • Terminated Z-0342-2016 FDA Class II initiated 9 Nov 2015 via P010015, on the same PMA

    Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

PMA

Full name
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P
Trade Name
Medtronic Insync(Tm) Biventrical Pacing System
Generic Name
Implantable pulse generator, pacemaker (non-CRT)
PMA Number
FDA Product Code
LWP
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

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Questions

  • What is the Percepta Bipolar CRT-P indicated for?

    The Percepta Bipolar CRT-P is indicated for the reduction of symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤35% and a QRS duration ≥130 ms.

  • What components are included in the Medtronic InSync biventricular pacing system with this device?

    The system includes the Model 8040 pulse generator, Model 9980 programmer software, and Attain LV Model 2187 and Attain CS Model 2188 leads.

  • What type of regulatory authorization does the Percepta Bipolar CRT-P have?

    The device has received FDA Premarket Approval (PMA) under number P010015.