FDA Registration
Active
🇺🇸 United States
Endurity family of pacemakers
Reg #: 2017865
·
FEI: 2017865
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABBOTT MEDICAL
- Registration Number
- 2017865
- FEI Number
- 2017865
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15900 Valley View Court
- City
- Sylmar
- State
- CA
- ZIP
- 91342
- Country
- US
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 |
|---|---|---|---|---|---|
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2015-02-06 |
Proprietary Names
Endurity family of pacemakers
Ellipse and Ellipse ST
AnalyST Accel
Fortify ST and Fortify Assura ST
Fortify
Fortify Assura
Establishment Types
Manufacture Device in the United States for Export Only