|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
Therapy and Therapy Dual-8
|
IRVINE BIOMEDICAL, INC. |
P040014 S043 |
03/24/2021 |
Therapy Ablation Catheter, Therapy 4MM Thermistor ...
|
IRVINE BIOMEDICAL, INC. |
P040014 S044 |
05/04/2021 |
Ampere™ Generator
|
IRVINE BIOMEDICAL, INC. |
P040014 S045 |
10/14/2021 |
IntellaNav ST Ablation Catheter, Blazer II Tempera...
|
Boston Scientific Corp. |
P920047 S124 |
08/05/2021 |
IntellaNav ST
|
Boston Scientific Corp. |
P920047 S125 |
09/07/2021 |
EZ Steer ThermoCool Nav Deflectable Diagnostic/Ab...
|
BIOSENSE WEBSTER, INC. |
P040036 S070 |
01/28/2021 |
ThermoCool SmartTouch SF Catheters
|
BIOSENSE WEBSTER, INC. |
P040036 S076 |
01/22/2021 |
EZ Steer Thermocool, EZ Steer Thermocool Bi-Direct...
|
BIOSENSE WEBSTER, INC. |
P040036 S077 |
02/02/2021 |
Thermocool Smarttouch
|
BIOSENSE WEBSTER, INC. |
P040036 S078 |
03/02/2021 |
Navistar Thermocool, EZ Steer Thermocool Nav Bi- D...
|
BIOSENSE WEBSTER, INC. |
P040036 S079 |
04/07/2021 |
|