|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
FlexAbility™ Ablation Catheter, Sensor Enabled™
|
Abbott Medical |
P110016 S080 |
12/14/2022 |
CELSIUS
|
Biosense Webster, Inc |
P950005 S082 |
03/08/2022 |
CELSIUS
|
Biosense Webster, Inc |
P950005 S084 |
09/09/2022 |
Celsius Catheter, Celsius RMT Catheter, Celsius FL...
|
Biosense Webster, Inc |
P950005 S085 |
09/30/2022 |
NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH
|
BIOSENSE WEBSTER, INC. |
P040036 S084 |
03/08/2022 |
ThermoCool SmartTouch SF
|
BIOSENSE WEBSTER, INC. |
P040036 S087 |
02/01/2022 |
NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST)
|
BIOSENSE WEBSTER, INC. |
P040036 S089 |
09/09/2022 |
ThermoCool SmartTouch Catheters, NaviStar ThermoCo...
|
BIOSENSE WEBSTER, INC. |
P040036 S090 |
09/30/2022 |
nGEN Pump
|
BIOSENSE WEBSTER, INC. |
P990071 S051 |
03/08/2022 |
SmartAblate Irrigation Tubing Set
|
BIOSENSE WEBSTER, INC. |
P990071 S053 |
03/15/2022 |
|