FDA Registration
Active
🇺🇸 United States
Passive Plus and Isoflex Lead Families, Passive Plus DX Endocardial Steroid Eluting, Passive Fixation Pacing Leads
Reg #: 2017865
·
FEI: 2017865
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
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
Regulatory Submissions
- PMA Number
- P960030
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 |
|---|---|---|---|---|---|
| Permanent Defibrillator Electrodes | NVY | Class 3 | Unknown | No | 2006-05-22 |
| Permanent Pacemaker Electrode | DTB | Class 3 | Cardiovascular | No | 2006-05-22 |
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | Class 3 | Unknown | No | 2006-05-22 |
Proprietary Names
Passive Plus and Isoflex Lead Families, Passive Plus DX Endocardial Steroid Eluting, Passive Fixation Pacing Leads
Establishment Types
Manufacture Medical Device