FDA Registration
Active
🇨🇷 Costa Rica
Abbott Medical Costa Rica Limitada (Structural Heart)
Reg #: 3014918977
·
FEI: 3014918977
·
Expires 2026
Products
8
Proprietary Names
29
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Abbott Medical Costa Rica Limitada (Structural Heart)
- Registration Number
- 3014918977
- FEI Number
- 3014918977
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Edificio #44 Calle 0, Ave. 2, Zona Franca Coyol
- City
- El Coyol Alajuela
- Country
- CR
Regulatory Submissions
- PMA Number
- P020024
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
US Agent
- Business Name
- Alessandra Chaves Sr Manager Structural Heart
- Contact Name
- Alessandra Chaves
- Address
- One Lillehei Plaza
- City
- Little Canada
- State
- MN
- ZIP
- 55117
- Country
- US
- [email protected]
- Phone
- 651 9555337
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Occluder, Patent Ductus, Arteriosus | MAE | Class 3 | Unknown | No | 2017-02-17 |
| Transcatheter Septal Occluder | MLV | Class 3 | Unknown | No | 2007-12-18 |
| Aortic Valve, Prosthesis, Percutaneously Delivered | NPT | Class 3 | Unknown | No | 2013-02-26 |
| Prosthesis, Mitral Valve, Percutaneously Delivered | NPU | Class 3 | Unknown | No | 2025-05-27 |
| Heart-Valve, Mechanical | LWQ | Class 3 | Unknown | No | 2007-10-16 |
| Heart-Valve, Non-Allograft Tissue | LWR | Class 3 | Unknown | No | 2007-10-16 |
| Replacement Heart-Valve | DYE | Class 3 | Cardiovascular | No | 2007-10-16 |
| System, Appendage Closure, Left Atrial | NGV | Class 3 | Unknown | No | 2021-08-14 |
Proprietary Names
Amplatzer Cardiac Plug (ACP)
Amplatzer Duct Occluder
Amplatzer Duct Occluder II
Amplatzer Piccolo Occluder
Amplatzer Cardiac Plug
Amplatzer Amulet Left Atrial Appendage Occluder
Tendyne Retrieval System
Tendyne Delivery System
Tendyne Stand Components
Tendyne Apical Pad
Tendyne Stand
Tendyne Mitral Valve
Tendyne Weight
Tendyne Pad Positioning System
Tendyne Loading System
Navitor Loading System
FlexNav Delivery System
FlexNav Loading System
Navitor Transcatheter Aortic Valve
Navitor Titan Transcatheter Aortic Valve
Navitor Loading System - LG+
Portico Transcatheter Aortic Valve
Epic Supra Valve (Aortic)
Epic Plus Supra Valve (Aortic)
Epic Plus Valve (Mitral)
Epic Plus Valve (Aortic)
Epic Valve (Mitral)
Epic Max Valve (Aortic)
Epic Valve (Aortic)
Establishment Types
Manufacture Medical Device