CAPSUREFIX(R)
FDA premarket approval P930039/S009 · decided 2000-08-31
Approval details
- PMA number
- P930039
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSUREFIX(R)
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2000-03-13
- Decision date
- 2000-08-31
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN EXTENDABLE/RETRACTABLE SCREW-IN PACING LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES MEDTRONIC CAPSURE(R)FIX NOVUS MODEL 5076 AND VITATRON CRYSTALLINE(R) ACTFIX MODEL ICF09 PACING LEADS. THESE DEVICES ARE INDICATED FOR PERMANENT PACING AND SENSING OF THE VENTRICLE AND/OR ATRIUM WHEN USED WITH A COMPATIBLE PULE GENERATOR.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| 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 |