FDA Registration
Active
🇺🇸 United States
Renamic
Reg #: 1028232
·
FEI: 1028232
·
Expires 2025
Products
5
Proprietary Names
16
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
- P070008
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 |
|---|---|---|---|---|---|
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2008-05-21 |
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | Class 3 | Unknown | No | 2008-05-21 |
| Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode | OJX | Class 3 | Unknown | No | 2008-05-21 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2008-05-21 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2008-05-21 |
Proprietary Names
Renamic
Home Monitoring
Evia HF(-T)
Entovis HF(-T)
PSW 1301.U
Enitra
Enticos
Evity
Sentus OTW QP L/S
Edora
LV-KIT
Corox
Stratos
ICS 3000
CardioMessenger
Celerity
Establishment Types
Repack or Relabel Medical Device