FDA Registration
Active
🇺🇸 United States
Linoxsmart
Reg #: 1028232
·
FEI: 1028232
·
Expires 2025
Products
5
Proprietary Names
34
Establishment Types
1
Classifications
5
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
- P980023
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 |
|---|---|---|---|---|---|
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2006-04-11 |
| Tester, Pacemaker Electrode Function | DTA | Class 2 | Cardiovascular | No | 2006-04-11 |
| Pulse-Generator, Pacemaker, External | DTE | Class 2 | Cardiovascular | No | 2006-04-11 |
| Permanent Defibrillator Electrodes | NVY | Class 3 | Unknown | No | 2006-04-11 |
| Programmer, Pacemaker | KRG | Class 3 | Cardiovascular | No | 2006-04-11 |
Proprietary Names
Linoxsmart
PA-11
PSW 1301.U
PA-4
Protego
COV
VL
BK-IS4/DF4
S 60
S-75
DF1-C6HV
IS1-C5PS
S-65
Si-2
TW
DH DF4
PA-10
SI-8
EFH
PK-44
IS4/DF4 Adapter
BSDF-1
Plexa
Plexa ProMRI S DX
Plexa ProMRI 60 cm
Kainox VCS
D2-KIT
ICS 3000
Vigila
Volta
Renamic
Linox
Pamira
D-KIT
Establishment Types
Repack or Relabel Medical Device