SYNCRA/CONSULTA CRT-P
FDA premarket approval P010015/S125 · decided 2011-07-01
Approval details
- PMA number
- P010015
- Supplement
- S125
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNCRA/CONSULTA CRT-P
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2011-05-19
- Decision date
- 2011-07-01
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL OF MODIFICATION TO THE 2490G SOFTWARE REQUIREMENTS SPECIFICATION TO ADD THE CRT-P DEVICE MODEL NUMBERS TO THE AUTO-ID LIST FOR THE MODEL 2020A CARDIOSIGHT READER.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |