DiamondTemp Ablation System
FDA premarket approval P200028/S013 · decided 2022-12-13
Approval details
- PMA number
- P200028
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DiamondTemp Ablation System
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Medtronic, Inc.
- Date received
- 2022-09-23
- Decision date
- 2022-12-13
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the release of a Universal Serial Bus (USB) tool to upgrade commercially distributed Radiofrequency (RF) Generator (CEDTG200) units from software V1.31 to V1.41.
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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 |
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