FDA Registration
Active
🇺🇸 United States
HeartWare Ventricular Assist System
Reg #: 3007042319
·
FEI: 3007042319
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HeartWare, Inc.
- Registration Number
- 3007042319
- FEI Number
- 3007042319
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14400 NW 60th Ave
- City
- Miami Lakes
- State
- FL
- ZIP
- 33014
- Country
- US
Regulatory Submissions
- PMA Number
- P100047
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventricular (Assist) Bypass | DSQ | Class 3 | Unknown | No | 2016-09-14 |
Proprietary Names
HeartWare Ventricular Assist System
Establishment Types
Manufacture Medical Device