# LWP · Implantable Pulse Generator, Pacemaker (Non-Crt)

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/CV-misc/LWP

## Overview

- **Product Code:** LWP
- **Device Name:** Implantable Pulse Generator, Pacemaker (Non-Crt)
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.

## Recent Cleared Devices (18 of 18)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P140033](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P140033.md) | Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software | ABBOTT MEDICAL | Jan 31, 2017 | APPR |
| [P150012](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P150012.md) | IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD | Boston Scientific | Apr 25, 2016 | APPR |
| [P090013](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P090013.md) | REVO MRI SURESCAN IPG AND PACING SYSTEM | Medtronic, Inc. | Feb 8, 2011 | APPR |
| [P010015](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P010015.md) | MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM | Medtronic, Inc. | Aug 28, 2001 | APPR |
| [N970003](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/N970003.md) | PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE | Boston Scientific Corp | Jun 3, 1999 | APPR |
| [P900022](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P900022.md) | CHORUS DDD PACEMAKER | MicroPort CRM USA, Inc. | Sep 6, 1991 | APPR |
| [P860027](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P860027.md) | MAESTRO SERIES 500 P.G. MODELS 501, 505, 509 | Cardiac Control Systems, Inc. | Feb 27, 1987 | APPR |
| [P840014](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P840014.md) | DDD PULSE GENERATOR 674 | Pacesetter Systems | Jul 31, 1986 | APPR |
| [P840068](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P840068.md) | DELTA PACEMAKER SYS; VIGOR DDD MODEL 950 | Boston Scientific | Nov 27, 1985 | APPR |
| [P830026](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P830026.md) | COSMOS(TM) SYSTEM | Boston Scientific | Mar 23, 1984 | APPR |
| [P830045](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P830045.md) | MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S | St. Jude Medical, Inc. | Mar 22, 1984 | APWD |
| [P820076](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P820076.md) | DIPLOS MODEL 05 A & B | Biotronik, Inc. | Feb 15, 1984 | APWD |
| [P830007](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P830007.md) | GEMINI(R) THETA MODEL 415A CARDIAC PACER | Telectronics Pacing Systems, Inc. | Nov 10, 1983 | APPR |
| [P820018](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P820018.md) | AUTIMA(TM) MODEL 2251 & MODEL 2600 | St. Jude Medical, Inc. | Feb 10, 1983 | APWD |
| [P820023](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P820023.md) | PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P | Pacesetter Systems | Feb 4, 1983 | APWD |
| [P820003](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P820003.md) | VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR | Medtronic Cardiac Rhythm Disease Management | Nov 16, 1982 | APPR |
| [P800019](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P800019.md) | CYBERLITH IV UNIPOLAR PULSE GENERATOR | Boston Scientific | Mar 6, 1981 | APWD |
| [P780009](https://fda.innolitics.com/submissions/CV/CV-misc/LWP/P780009.md) | BYREL PROGRAMABLE PACEMAKER | Medtronic Cardiac Rhythm Disease Management | Mar 27, 1979 | APWD |

## Top Applicants

- Boston Scientific — 4 clearances
- Medtronic Cardiac Rhythm Disease Management — 2 clearances
- Medtronic, Inc. — 2 clearances
- Pacesetter Systems — 2 clearances
- St. Jude Medical, Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/CV/CV-misc/LWP](https://fda.innolitics.com/submissions/CV/CV-misc/LWP)

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