FDA Registration
Active
🇺🇸 United States
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
Reg #: 1225687
·
FEI: 3001451463
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Boston Scientific Corp., Marina Bay Cust. Fulfillment Center
- Registration Number
- 1225687
- FEI Number
- 3001451463
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 500 Commander Shea Boulevard
- City
- QUINCY
- State
- MA
- ZIP
- 02171
- 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
Manufacture Medical Device