FDA Registration
Active
🇺🇸 United States
HMSC Version 3.63
Reg #: 1028232
·
FEI: 1028232
·
Expires 2025
Products
11
Proprietary Names
97
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- BIOTRONIK, INC.
- Registration Number
- 1028232
- FEI Number
- 1028232
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6024 JEAN RD.
- City
- LAKE OSWEGO
- State
- OR
- ZIP
- 97035
- Country
- US
Regulatory Submissions
- PMA Number
- P950037
Owner / Operator
- Firm Name
- BIOTRONIK, INC.
- Operator Number
- 1028232
- Address
- 6024 JEAN RD., --
- City
- Lake Oswego
- State
- OR
- Postal Code
- 97035
- Country
- US
- Correspondent
- JON - BRUMBAUGH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Permanent Pacemaker Electrode | DTB | Class 3 | Cardiovascular | No | 2008-05-21 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2008-05-21 |
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | Class 3 | Unknown | No | 2008-05-21 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2008-05-21 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2008-05-21 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2008-05-21 |
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2008-05-21 |
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | Class 3 | Unknown | No | 2008-05-21 |
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | Class 3 | Unknown | No | 2008-05-21 |
| Pulse Generator, External Pacemaker, Dual Chamber | OVJ | Class 2 | Cardiovascular | No | 2008-05-21 |
| Programmer, Pacemaker | KRG | Class 3 | Cardiovascular | No | 2008-05-21 |
Proprietary Names
HMSC Version 3.63
HMSC Version 3.62
CardioMessenger
Solox
PK-222
DH
Entovis
S 60
BS IS-1 Blind Plug
S 58
S 53
S 45
PK-155
NK-29
Etrinsa
PK-83
PK-175
EFH
Eluna
Solia
PSW 1506.U
Safio
Evity
PSW 1507.U
Edora
PSW 1506.U/1
PSW 1702.U
PSW 1703.U
EFH-6F-W
HMSC Version 3.39
HMSC Version 3.41
PSW 1801.U
HMSC Version 3.42
HMSC Version 3.40
PSW 1704.U
PSW 1901.U
Solia T/JT
PSW 1804.U
HMSC Version 3.47
HMSC Version 3.45
HMSC Version 3.48
HMSC Version 3.44
HMSC Version 3.43
PSW 1904.U
PK-155-B
PK-222-L ECG Cable
PSW 2100.U
NEO 2100.U
PSW 2100.U/1
PSW 2201.U/1
Renamic Neo Programmer
NEO 2201.U/1
HMSC Version 3.53
HMSC Version 3.54
Ecuro
Evia
EDP
Dextrus
NEO 2204.U
PSW 2301.U
NEO 2303.U
Amvia
HMSC Version 3.58
NEO 2202.U
HMSC Version 3.60
Model 6652
Model 3171
Reocor
Model 3175
PSW 2204.U
HMSC 3.55
Renamic Neo NEOexpress
PSW 2401.U
NEO 2401.U
Model 3145
M-50 Magnet
P-KIT
Selox
Solvia
Model 3150
NEO 2302.U
ICS 3000
Renamic
Reliaty
Tilda
HMSC Version 3.57
Estella
Effecta
Model 6646
PSW 2202.U
NEO 2301.U
Model 6653
PSW 2302.U
NEO 2401.U/1
Setrox S
PSW 2303.U
Home Monitoring
Establishment Types
Repack or Relabel Medical Device