Panels › Cardiovascular › Product code PNJ · Class 3
Leadless Pacemaker
Regulation 870.3610
0510(k)s in 12 months (0 all time)
1recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in PNJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Medical | 0 | 4 |
| Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2026 | Abbott Medical Merlin" Patient Care System (PCS) software
Merlin" PCS 3650 programmer Model 3330 software Open, Classified |
PNJ | None listed |
| Apr 14, 2025 | Abbott Medical Aveir DR Leadless Pacemaker (LP) Ventricular Device
REF LSP202V
UDI-DI code: 05415067040725
REF LSP112V
UDI-DI code: 05415067034472
The Aveir leadless pacemaker system supports the implantation and Open, Classified |
PNJ | None listed |
| Dec 23, 2024 | Abbott Medical The Merlin PCS 3650 programmer Model 3330
The Merlin PCS programmer model 3650 is a portable, dedicated
programming system which operates using the Merlin PCS Model 3330
software and is designed to i Open, Classified |
PNJ | None listed |
| Apr 29, 2024 | Abbott Medical Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO Open, Classified |
PNJ | None listed |
| Sep 9, 2019 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker. Terminated |
PNJ | None listed |
| Sep 9, 2019 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker. Terminated |
PNJ | None listed |
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