Product code LWP ยท Class 3
Implantable Pulse Generator, Pacemaker (Non-Crt)
0510(k)s in 12 months (0 all time)
1recalls in 12 months (113 all time)
0recalls that name a 510(k)
Top companies in LWP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2026 | Boston Scientific Corporation Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as:
1. ESSENTIO SR SL, Model Number L100;
2. ESSENTIO DR SL Pacemaker, Model Nu Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number S722, ALTRUA 2 DR EL Pacemaker Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number S702, ALTRUA 2 DR SL Pacemaker Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number S701 ALTRUA 2 SR SL Pacemaker Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number L131, ESSENTIO DR EL MRI Pacemaker Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number L121 ESSENTIO DR EL Pacemaker Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number L111, ESSENTIO DR SL MRI Pacemaker Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number L110, ESSENTIO SR SL MRI Pacemaker Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number L100, ESSENTIO SR SL Pacemaker Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number L231, PROPONENT DR EL MRI Pacemaker Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number L221 PROPONENT DR EL Pacemaker Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number L211 PROPONENT DR SL MRI Pacemaker Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number L210 PROPONENT SR SL Pacemaker Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number L209 PROPONENT DR (VDD) SL Pacemaker Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation PROPONENT DR SL (Model L201) Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation PROPONENT SR SL (Model L200) Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation ACCOLADE DR EL MRI (Model L331) Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation ACCOLADE DR EL (Model L321) Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation ACCOLADE DR SL MRI (Model L311) Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation ACCOLADE SR SL MRI (Model L310) Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation ACCOLADE DR SL (Model L301) Open, Classified |
LWP | None listed |
| Oct 10, 2025 | Boston Scientific Corporation ACCOLADE SR SL (Model L300) Open, Classified |
LWP | None listed |
| Jan 10, 2025 | Boston Scientific Corporation ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) Open, Classified |
LWP | None listed |
| Jan 10, 2025 | Boston Scientific Corporation ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131) Open, Classified |
LWP | None listed |
| Jan 10, 2025 | Boston Scientific Corporation PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231). Open, Classified |
LWP | None listed |
| Jan 10, 2025 | Boston Scientific Corporation ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331) Open, Classified |
LWP | None listed |
| Jul 13, 2021 | Boston Scientific Corporation VITALIO DR EL (pacemaker), Model Numbers:
a) J274
b) J277
c) K274 (added 7/15/2021)
d) K277 (added 7/15/2021)
e) K284 (added 7/15/2021)
f) K287 (added 7/15/2021) Open, Classified |
LWP | None listed |
| Jul 13, 2021 | Boston Scientific Corporation INGENIO DR EL (pacemakers), Model Numbers:
a) J174
b) J177
c) K174 (added 7/15/2021)
d) K184 (added 7/15/2021)
e) K187 (added 7/15/2021) Open, Classified |
LWP | None listed |
| Jul 13, 2021 | Boston Scientific Corporation ADVANTIO DR EL (pacemaker), Model Numbers:
a) J064
b) J067
c) K064 (added 7/15/2021)
d) K084 (added 7/15/2021)
e) K087 (added 7/15/2021) Open, Classified |
LWP | None listed |
| Jul 2, 2021 | Boston Scientific Corporation Altrua 2 pacemaker, Models:
a) S701
b) S702
c) S722 Open, Classified |
LWP | None listed |
| Jul 2, 2021 | Boston Scientific Corporation Accolade pacemaker, Models:
a) L300
b) L301
c) L310
d) L311
e) L321
f) L331 Open, Classified |
LWP | None listed |
| Jul 2, 2021 | Boston Scientific Corporation Proponent pacemaker, Models:
a) L200
b) L201
c) L209
d) L210
e) L211
f) L221
g) L231 Open, Classified |
LWP | None listed |
| Jul 2, 2021 | Boston Scientific Corporation Essentio pacemaker, Models:
a) L100
b) L101
c) L110
d) L111
e) L121
f) L131 Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation PROPONENT MRI Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation PROPONENT VDD SL Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation PROPONENT EL DR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation PROPONENT DR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation PROPONENT SR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation ESSENTIO MRI EL DR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation ESSENTIO EL DR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation ESSENTIO MRI DR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation ESSENTIO MRI SR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation ESSENTIO DR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation ESSENTIO SR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation ALTRUA 2 EL DR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation ALTRUA 2 DR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation ALTRUA 2 SR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation ACCOLADE MRI EL DR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation ACCOLADE MRI DR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation ACCOLADE MRI SR Pacemaker Open, Classified |
LWP | None listed |
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