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