AV Plus™
by St. Jude Medical Cardiac Rhythm Management Division
Ref 1368/58Model 1358/58
Active
CE AIMDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/AIMDD | NumberB-05414734005135 05414734005135 | Date17 Jul 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/AIMDD Active
Specification
- Device Name
- AV Plus Dx
- Model / Reference
- 1358/58, 1368/58
- Primary DI / UDI-DI
- 05414734005135
- Basic UDI-DI
- B-05414734005135
- EMDN Code
- J0190010102 Endocardial atrial and ventricular leads, bipolar (with active or passive fixation)
- Device Class
- Class AIMDD
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000010382
- Authorised representative
- St. Jude Medical Coordination Center BE-AR-000008417
Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No