FDA Registration
Active
🇺🇸 United States
INOGEN EL
Reg #: 2124215
·
FEI: 2124215
·
Expires 2025
Products
4
Proprietary Names
14
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Boston Scientific Corporation
- Registration Number
- 2124215
- FEI Number
- 2124215
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4100 Hamline Ave N
- City
- Saint Paul
- State
- MN
- ZIP
- 55112
- Country
- US
Regulatory Submissions
- PMA Number
- P960040
Owner / Operator
- Firm Name
- Boston Scientific Corporation
- Operator Number
- 9912058
- Address
- 300 Boston Scientific Way
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2010-10-26 |
| Programmer, Pacemaker | KRG | Class 3 | Cardiovascular | No | 2010-10-26 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2010-10-26 |
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | Class 3 | Unknown | No | 2010-10-26 |
Proprietary Names
INOGEN EL
DYNAGEN MINI
DYNAGEN EL
INOGEN MINI
RESONATE EL ICD
MOMENTUM EL ICD
PERCIVA HF ICD
PERCIVA ICD
AUTOGEN EL
VIGILIANT EL ICD
RESONATE HF ICD
INCEPTA
ENERGEN
PUNCTUA
Establishment Types
Manufacture Medical Device