Essentio™ El Dr L121
Essentio™ El Dr L121 is a Class III device made by Boston Scientific, listed under FDA premarket submission N970003 on 12 Mar 2013 and listed in FDA GUDID since 11 Nov 2014 (UDI-DI 00802526558986), active as of 22 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00802526558986 | Date11 Nov 2014 | StatusListed |
| United States | FDA PMAAPPR | NumberN970003 | Date12 Mar 2013 | StatusActive |
Official records
- AccessGUDID record 00802526558986
Across registries
- FDA premarket submission N970003 decided 12 Mar 2013 Active
- FDA GUDID UDI-DI 00802526558986 listed 11 Nov 2014 Listed
Timeline
- Decided FDA premarket submission N970003
- Listed FDA GUDID 00802526558986
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Essentio™ El Dr
- Generic name
- Dual-chamber implantable pacemaker, rate-responsive
- Model / Ref / Catalog
- L121
- Primary DI / UDI-DI
- 00802526558986
- FDA product code
- LWP
- GMDN term
- Dual-chamber implantable pacemaker, rate-responsive
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code LWP (Implantable pulse generator, pacemaker (non-CRT)).
- 2292 by MEDTRONIC, INC.
- Aurora Models 6291 and 6292 Pacemakers by ST. JUDE MEDICAL, INC.
- Percepta Bipolar CRT-P by MEDTRONIC, INC.
- Paragon/Phoenix Family of Pacemakers by ST. JUDE MEDICAL, INC.
- DDD Pulse Generator 674 by Pacesetter Systems
- PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P by Pacesetter Systems
- Chorus DDD Pacemaker by MicroPort CRM USA, Inc.
- Gemini Theta Model 415A Cardiac Pacer by Telectronics Pacing Systems, Inc.
- Versatrax Model 7000 Universal A-V Pulse Generator by Medtronic Cardiac Rhythm Disease Management
- Tendril MRI Lead (Model LPA 1200M) by Abbott Medical