CONSULTA CRT-P,SYNCRA CRT-P
FDA premarket approval P010015/S229 · decided 2014-02-27
Approval details
- PMA number
- P010015
- Supplement
- S229
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONSULTA CRT-P,SYNCRA CRT-P
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Medtronic, Inc.
- Date received
- 2013-12-19
- Decision date
- 2014-02-27
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR SOFTWARE CHANGES TO THE MYCARELINK PATIENT MONITOR M2.5 MODEL 24950 WITH MODEL 24955 RF HEAD WHICH SUPPORTS THE DEVICES AND MEDTRONIC¿S REVEAL INSERTABLE CARDIAC MONITORS MODELS 9529, 9528 AND LNQ11. THE MYCARELINK PATIENT MONITOR IS INDICATED FOR TRANSMISSION OF IMPLANTABLE DEVICE DATA TO THE CARELINK NETWORK FOR THE CLINIC TO REVIEW.
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510(k) clearances by this applicant
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|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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| 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 |