FDA Registration
Active
🇮🇪 Ireland
INTUA
Reg #: 9616693
·
FEI: 3002618605
·
Expires 2025
Products
3
Proprietary Names
7
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Boston Scientific Limited
- Registration Number
- 9616693
- FEI Number
- 3002618605
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Cashel Road
- City
- CLONMEL Tipperary
- Country
- IE
Regulatory Submissions
- PMA Number
- P030005
Owner / Operator
- Firm Name
- Boston Scientific Corporation
- Operator Number
- 9912058
- Address
- 300 Boston Scientific Way
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
US Agent
- Business Name
- Boston Scientific Corporation
- Contact Name
- Aaron Dunbar
- Address
- 300 Boston Scientific Way
- City
- Marlborough
- State
- MA
- ZIP
- 01752
- Country
- US
- [email protected]
- Phone
- 651 3961414
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Permanent Pacemaker Electrode | DTB | Class 3 | Cardiovascular | No | 2010-10-26 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2010-10-26 |
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | Class 3 | Unknown | No | 2010-10-26 |
Proprietary Names
INTUA
VALITUDE X4
VALITUDE
VISIONIST X4
VISIONIST
INVIVE
CONTAK RENEWAL TR Software Application
Establishment Types
Manufacture Medical Device