|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
ACUITY X4 lead family shelf life
|
Boston Scientific Corp. |
P010012 S437 |
12/21/2016 |
ACUITY X4 Lead Models 4671, 4672, 4674, 4675, 4677...
|
Boston Scientific Corp. |
P010012 S440 |
12/19/2016 |
AMPLIA MRI CRT-D & QUAD CRT-D; BRAVA CRT-D & QUAD ...
|
MEDTRONIC CARDIAC RHYTHM DISEA |
P010031 S574 |
12/19/2016 |
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE C...
|
MEDTRONIC CARDIAC RHYTHM DISEA |
P010031 S571 |
12/14/2016 |
AUTOGEN X4 CRT-D MODEL G166, G168 and AUTOGEN CRT-...
|
Boston Scientific Corp. |
P010012 S424 |
12/12/2016 |
Claria MRI CRT-D QUAD SureScan; Amplia MRI Quad CR...
|
MEDTRONIC CARDIAC RHYTHM DISEA |
P010031 S568 |
11/23/2016 |
Brava CRT-D; Brava Quad CRT-D; Concerto ICD,II CRT...
|
MEDTRONIC CARDIAC RHYTHM DISEA |
P010031 S560 |
11/17/2016 |
PROMOTE, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA...
|
Abbott Medical |
P030054 S313 |
11/17/2016 |
QuickFlex and Quartet Leads
|
Abbott Medical |
P030054 S312 |
11/06/2016 |
Brava,Brava Quad CRT-D; Viva S, XT,Viva Quad S, XT...
|
MEDTRONIC CARDIAC RHYTHM DISEA |
P010031 S566 |
11/02/2016 |