|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
Blazer II Cardiac Ablation Catheter and Cable
|
Boston Scientific Corp. |
P920047 S118 |
11/07/2019 |
Blazer II XP, Blazer Prime HTD, Blazer Prime XP Ca...
|
Boston Scientific Corp. |
P920047 S116 |
06/17/2019 |
Blazer II, Blazer II HTD, Blazer Prime HTD, Intell...
|
Boston Scientific Corp. |
P920047 S115 |
05/03/2019 |
Celsius Catheter
|
Biosense Webster, Inc |
P950005 S072 |
08/02/2019 |
Celsius RMT Catheter; Navistar RMT Thermocool Cath...
|
Biosense Webster, Inc |
P950005 S071 |
03/08/2019 |
Chilli II
|
Boston Scientific Corp. |
P980003 S089 |
05/03/2019 |
Chilli II Cooled Ablation Catheter and Cable
|
Boston Scientific Corp. |
P980003 S091 |
11/07/2019 |
CoolFlow Irrigation Tubing Set
|
BIOSENSE WEBSTER, INC. |
P990071 S040 |
05/08/2019 |
Electrophysiology Cable, Therapy Ablation Catheter
|
IRVINE BIOMEDICAL, INC. |
P040014 S036 |
04/11/2019 |
EZ Steer Thermocool NAV Catheter and Navistar Ther...
|
BIOSENSE WEBSTER, INC. |
P040036 S068 |
08/02/2019 |
|