DiamondTemp Ablation System
FDA premarket approval P200028/S004 · decided 2021-05-28
Approval details
- PMA number
- P200028
- Supplement
- S004
- 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
- 2021-03-01
- Decision date
- 2021-05-28
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the addition of the DiamondTemp Generator Connection Box E (Model: CEDTGCB100) device to the DiamondTemp Ablation System.
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