FDA Registration
Active
🇺🇸 United States
MitraClip Clip Delivery System
Reg #: 3020950818
·
FEI: 3020950818
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Abbott Medical
- Registration Number
- 3020950818
- FEI Number
- 3020950818
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1820 Bastian Court
- City
- Westfield
- State
- IN
- ZIP
- 46074
- Country
- US
Regulatory Submissions
- PMA Number
- P100009
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mitral Valve Repair Devices | NKM | Class 3 | Unknown | No | 2013-11-22 |
Proprietary Names
MitraClip Clip Delivery System
MitraClip G4 System
MitraClip G5 Delivery system
Establishment Types
Manufacture Medical Device