MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT
FDA premarket approval P920015/S022 · decided 2001-06-15
Approval details
- PMA number
- P920015
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2001-05-31
- Decision date
- 2001-06-15
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODEL 6726 DF-1 Y-ADAPTOR/EXTENDER KIT. THE DEVICE IS INDICATED TO ADAPT TWO DF-1 LEAD CONNECTORS TO A SINGLE DF-1 COMPATIBLE CONNECTOR PORT AND/OR WILL EXTEND THE LENGTH OF A DF-1 LEAD CONNECTOR. THE MODEL 6726 HAS APPLICATION FOR PATIENTS IN WHICH IDC SYSTEMS ARE INDICATED.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |