FDA Registration
Active
🇺🇸 United States
Lead Stabilizer Kit
Reg #: 2648729
·
FEI: 2648729
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Boston Scientific Corporation
- Registration Number
- 2648729
- FEI Number
- 2648729
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 12, RD. No. 698
- City
- Dorado
- State
- PR
- ZIP
- 00646
- Country
- US
Regulatory Submissions
- PMA Number
- P960006
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 |
|---|---|---|---|---|---|
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | Class 3 | Unknown | No | 2010-10-28 |
| Permanent Defibrillator Electrodes | NVY | Class 3 | Unknown | No | 2010-10-28 |
| Permanent Pacemaker Electrode | DTB | Class 3 | Cardiovascular | No | 2010-10-28 |
Proprietary Names
Lead Stabilizer Kit
Fixation Tool
FLEXTEND
Establishment Types
Manufacture Medical Device