|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
RESONATE™ HF, RESONATE™, RESONATE™ X4, MOMENTUM™, ...
|
Boston Scientific Corp. |
P010012 S552 |
08/26/2022 |
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT...
|
MEDTRONIC CARDIAC RHYTHM DISEA |
P010031 S800 |
08/25/2022 |
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C...
|
MEDTRONIC CARDIAC RHYTHM DISEA |
P010031 S798 |
08/16/2022 |
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C...
|
MEDTRONIC CARDIAC RHYTHM DISEA |
P010031 S797 |
08/08/2022 |
Quickflex µ, Quartet
|
Abbott Medical |
P030054 S400 |
08/01/2022 |
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT...
|
MEDTRONIC CARDIAC RHYTHM DISEA |
P010031 S795 |
07/25/2022 |
Momentum CRT-D, Momentum X4 CRT-D, ICD Inogen CRT-...
|
Boston Scientific Corp. |
P010012 S556 |
07/22/2022 |
CareLink SmartSync Cobalt/Crome App, Cobalt MRI CR...
|
MEDTRONIC CARDIAC RHYTHM DISEA |
P010031 S791 |
07/20/2022 |
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT...
|
MEDTRONIC CARDIAC RHYTHM DISEA |
P010031 S793 |
07/19/2022 |
Avant HF, Neutrino NxT HF, Gallant HF, and Entrant...
|
Abbott Medical |
P030054 S399 |
07/14/2022 |