|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
Avant, Neutrino NxT, Gallant, Entrant, Unify, Unif...
|
Abbott Medical |
P030054 S417 |
02/21/2024 |
Avant, Gallant, Entrant, Neutrino NxT Family of CR...
|
Abbott Medical |
P030054 S419 |
05/01/2024 |
Entrant CRT-D, Gallant CRT D, Neutrino NxT HF CRT-...
|
Abbott Medical |
P030054 S420 |
05/14/2024 |
Unify, Unify Quadra, Unify Assura, Quadra Assura, ...
|
Abbott Medical |
P030054 S421 |
05/22/2024 |
Butylated Hydroxytoluene (BHT)
|
Boston Scientific Corp. |
P010012 S579 |
01/03/2024 |
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN,...
|
Boston Scientific Corp. |
P010012 S580 |
04/30/2024 |
ACUITY X4™ Straight, ACUITY X4 Spiral S, ACUITY X4...
|
Boston Scientific Corp. |
P010012 S583 |
05/22/2024 |
G124 MOMENTUM™ CRT-D, G125 MOMENTUM™ CRT-D, G126 M...
|
Boston Scientific Corp. |
P010012 S584 |
05/29/2024 |
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT...
|
MEDTRONIC CARDIAC RHYTHM DISEA |
P010031 S844 |
01/12/2024 |
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT...
|
MEDTRONIC CARDIAC RHYTHM DISEA |
P010031 S845 |
02/16/2024 |
|