|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
PSW 2303.U, NEO 2303.U
|
BIOTRONIK, INC. |
P070008 S151 |
12/13/2023 |
Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-...
|
BIOTRONIK, INC. |
P070008 S155 |
11/02/2023 |
Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Ev...
|
BIOTRONIK, INC. |
P070008 S153 |
10/27/2023 |
Evity 8 F-T QP, Evity 8 HF-T, Enticos 8 HF-T QP, E...
|
BIOTRONIK, INC. |
P070008 S154 |
10/24/2023 |
Pulse Generator, Pacemaker, Implantable, With Card...
|
BIOTRONIK, INC. |
P070008 S152 |
10/23/2023 |
PSW 2302.U, NEO 2302.U
|
BIOTRONIK, INC. |
P070008 S150 |
08/21/2023 |
Drug Eluting Permanent Left Ventricular (LV) Pacem...
|
BIOTRONIK, INC. |
P070008 S149 |
06/28/2023 |
Pacemaker/ICD/CRT non-implanted components
|
BIOTRONIK, INC. |
P070008 S144 |
06/28/2023 |
Home Monitoring System Version 3.56.0
|
BIOTRONIK, INC. |
P070008 S147 |
05/11/2023 |
PSW 2301.U, NEO 2301.U
|
BIOTRONIK, INC. |
P070008 S146 |
04/13/2023 |
|