FDA Registration
Active
🇺🇸 United States
Superion IDS, 12 mm
Reg #: 3006630150
·
FEI: 3006630150
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Boston Scientific Neuromodulation Corporation
- Registration Number
- 3006630150
- FEI Number
- 3006630150
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 25155 Rye Canyon Loop
- City
- Valencia
- State
- CA
- ZIP
- 91355
- Country
- US
Regulatory Submissions
- PMA Number
- P140004
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 |
|---|---|---|---|---|---|
| Prosthesis, Spinous Process Spacer/Plate | NQO | Class 3 | Unknown | No | 2019-11-14 |
Proprietary Names
Superion IDS, 12 mm
Superion IDS, 10 mm
Single Use Instrument (SUI) Kit
Superion IDS, 14 mm
Vertiflex Instrument Platform (VIP) Kit
Superion IDS, 8 mm
Superion IDS, 16 mm
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility