FDA Registration
Active
🇺🇸 United States
St Jude Medical MR Conditional Pacemaker System
Reg #: 3013288201
·
FEI: 3013288201
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ABBOTT MEDICAL
- Registration Number
- 3013288201
- FEI Number
- 3013288201
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14901 Deveau Pl. Building 2
- City
- Minnetonka
- State
- MN
- ZIP
- 55345
- Country
- US
Regulatory Submissions
- PMA Number
- P140033
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 |
|---|---|---|---|---|---|
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | Class 3 | Unknown | No | 2017-01-31 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2017-01-31 |
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2017-01-31 |
Proprietary Names
St Jude Medical MR Conditional Pacemaker System
Establishment Types
Complaint File Establishment per 21 CFR 820.198