ENTRUST ICD AND THE CARDIOSIGHT READER
FDA premarket approval P890003/S105 · decided 2006-07-12
Approval details
- PMA number
- P890003
- Supplement
- S105
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENTRUST ICD AND THE CARDIOSIGHT READER
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2006-06-19
- Decision date
- 2006-07-12
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR ADDING SUPPORT FOR THE CONCERTO MODEL C154DWK AND VIRTUOSO MODELS D154AWG/D154VWC TO THE MODEL 2020A CARDIOSIGHT READERS AND THE CORRECTION OF AN ANOMALY IN THE MODEL 2491 DDMA AFFECTING THE ENTRUST FAMILY OF ICDS.
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510(k) clearances by this applicant
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|---|---|---|
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| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |