PACEART SYSTEM
FDA 510(k) clearance K024278 · decided 2003-05-29
Clearance details
- K-number
- K024278
- Device name
- PACEART SYSTEM
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 2002-12-23
- Decision date
- 2003-05-29
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- DPS
- Device class
- 2
- Regulation number
- 870.2340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis recall (Z-0081-2008) | Medtronic Inc. Cardiac Rhythm Managment | 2007-11-06 |
| Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart recall (Z-0911-06) | Medtronic Inc. Cardiac Rhythm Managment | 2006-05-31 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089) | Medtronic Vascular | 2025-12-19 |
| Endurant II/IIs Stent Graft System (P100021/S131) | Medtronic Vascular | 2025-10-23 |
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| Resolute Onyx (P160043/S088) | Medtronic Vascular | 2025-06-26 |
| Endurant Stent Graft System (P100021/S130) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072) | Medtronic Vascular | 2025-05-20 |
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