|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
Ampere™ Generator
|
IRVINE BIOMEDICAL, INC. |
P060019 S054 |
10/14/2021 |
Ampere™ Generator, Ampere™ Remote Control, Ampere™...
|
IRVINE BIOMEDICAL, INC. |
P060019 S055 |
11/29/2023 |
Cool Point Irrigation Pump
|
IRVINE BIOMEDICAL, INC. |
P060019 S043 |
08/16/2019 |
Cool Point Tubing Set
|
IRVINE BIOMEDICAL, INC. |
P060019 S041 |
11/02/2017 |
COOL POINT TUBING SET
|
IRVINE BIOMEDICAL, INC. |
P060019 S014 |
10/29/2010 |
COOL POINT(TM) TUBING SET
|
IRVINE BIOMEDICAL, INC. |
P060019 S025 |
05/19/2014 |
IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500...
|
IRVINE BIOMEDICAL, INC. |
P060019 S036 |
02/29/2016 |
IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500...
|
IRVINE BIOMEDICAL, INC. |
P060019 |
03/16/2007 |
SAFIRE BLU AND THERAPY COOL BI-DIRECTIONAL ABLATIO...
|
IRVINE BIOMEDICAL, INC. |
P060019 S023 |
11/29/2012 |
SAFIRE BLU AND THERAPY COOL PATH BI-DIRECTIONAL AB...
|
IRVINE BIOMEDICAL, INC. |
P060019 S016 |
12/23/2010 |
|