FDA Registration
Active
🇺🇸 United States
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
Reg #: 2124215
·
FEI: 2124215
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
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
- P130013
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 |
|---|---|---|---|---|---|
| System, Appendage Closure, Left Atrial | NGV | Class 3 | Unknown | No | 2015-03-17 |
Proprietary Names
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System
Establishment Types
Complaint File Establishment per 21 CFR 820.198