FDA Registration
Active
🇨🇷 Costa Rica
Carpentier-Edwards Perimount Bioprosthesis
Reg #: 3015287573
·
FEI: 3015287573
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Edwards Lifesciences
- Registration Number
- 3015287573
- FEI Number
- 3015287573
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Zona Franca La Lima, De la entrada de Pequeno Mundo 100 mts oeste y 200 mts sur, Finca 31 y 32
- City
- Guadalupe Cartago
- Country
- CR
Regulatory Submissions
- PMA Number
- P860057
Owner / Operator
- Firm Name
- Edwards Lifesciences LLC
- Operator Number
- 9040666
- Address
- One Edwards Way
- City
- Irvine
- State
- CA
- Postal Code
- 92614
- Country
- US
- Correspondent
- Denny Kouri
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Replacement Heart-Valve | DYE | Class 3 | Cardiovascular | No | 2008-01-17 |
Proprietary Names
Carpentier-Edwards Perimount Bioprosthesis
Establishment Types
Manufacture Medical Device