MEDTRONIC(R) TRANSVENE LEAD SYSTEM
FDA premarket approval P920015/S175 · decided 2016-08-24
Approval details
- PMA number
- P920015
- Supplement
- S175
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC(R) TRANSVENE LEAD SYSTEM
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2016-03-01
- Decision date
- 2016-08-24
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the expansion of MRI conditional labeling for the Amplia MRI and Compia MRI Systems to include 3T MRI.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |