FDA Registration
Active
🇺🇸 United States
HeartMate 3 LVAS
Reg #: 2916596
·
FEI: 2916596
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- THORATEC CORP.
- Registration Number
- 2916596
- FEI Number
- 2916596
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6035 Stoneridge Dr
- City
- PLEASANTON
- State
- CA
- ZIP
- 94588
- Country
- US
Regulatory Submissions
- PMA Number
- P160054
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 |
|---|---|---|---|---|---|
| Ventricular (Assist) Bypass | DSQ | Class 3 | Unknown | No | 2018-02-16 |
Proprietary Names
HeartMate 3 LVAS
Establishment Types
Manufacture Medical Device