|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
Cardiac Resynchronization Therapy Defibrillator (C...
|
Boston Scientific Corp. |
P010012 S485 |
06/01/2018 |
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 |
Easytrak 2, Easytrack 3, Acuity Sprial, Acuity X4
|
Boston Scientific Corp. |
P010012 S488 |
07/26/2018 |
Dynagen CRT-D, Dynagen X4 CRT-D, Inogen CRT-D, Ino...
|
Boston Scientific Corp. |
P010012 S489 |
09/04/2018 |
CRT-Ds Autogen, Inogen, Dynagen, Origen, Resonate,...
|
Boston Scientific Corp. |
P010012 S490 |
10/10/2018 |
ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILA...
|
Boston Scientific Corp. |
P010012 S491 |
11/16/2018 |
QuickFlex u and Quartet leads
|
Abbott Medical |
P030054 S323 |
04/02/2018 |
Slit Suture Sleeve; Vein Pick
|
Abbott Medical |
P030054 S343 |
01/05/2018 |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni...
|
Abbott Medical |
P030054 S344 |
04/11/2018 |
|