|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
Dynagen CRT-D, Dynagen X4 CRT-D, Inogen CRT-D, Ino...
|
Boston Scientific Corp. |
P010012 S489 |
09/04/2018 |
MANAGE HF Study
|
Boston Scientific Corp. |
P010012 S486 |
08/21/2018 |
Longitudinal Surveillance Registry of the ACUITY S...
|
Boston Scientific Corp. |
P010012 S487 |
08/20/2018 |
ACUITYX4 Lead Straight, ACUITY X4 Lead Spiral S, A...
|
Boston Scientific Corp. |
P010012 S484 |
07/27/2018 |
Easytrak 2, Easytrack 3, Acuity Sprial, Acuity X4
|
Boston Scientific Corp. |
P010012 S488 |
07/26/2018 |
Cardiac Resynchronization Therapy Defibrillator (C...
|
Boston Scientific Corp. |
P010012 S485 |
06/01/2018 |
Acuity Spiral Lead Family, Acuity X4 Lead Family
|
Boston Scientific Corp. |
P010012 S483 |
05/16/2018 |
Contak CD,Easytrak, Livian, Cognis and Acuity Spir...
|
Boston Scientific Corp. |
P010012 S482 |
04/25/2018 |
Cognis, Energen, Punctua, Incepta, Origen, Inogen,...
|
Boston Scientific Corp. |
P010012 S477 |
03/26/2018 |
RSONATE, MOMENTUM and VIGILANT NG4 CRT-DS
|
Boston Scientific Corp. |
P010012 S480 |
03/22/2018 |
|