|
Device |
catheter, electrode recording, or probe, electrode recording |
Product Code | DRF |
Regulation Number |
870.1220
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACCESS POINT TECHNOLOGIES EP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAYLIS MEDICAL COMPANY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOSENSE WEBSTER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
BIOTRONICK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOTRONIK, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CATHRXLTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVATIVE HEALTH, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MEDFACT ENGINEERING GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC ABLATION FRONTIERS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RHYTHMIA MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHANGHAI MICROPORT EP MEDTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ST. JUDE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
SYNAPTIC MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNAPTIC MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Premarket Approvals (PMA) |
2009 |
2010 |
2011 |
2012 |
2013 |
2014 |
2015 |
2016 |
2017 |
2018 |
2019 |
2020 |
2021 |
2022 |
2023 |
2024 |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
6
|
1
|
1
|
3
|
7
|
3
|
1
|
0
|
|
|
|
|