- Device
- DiamondTemp Ablation System
- Applicant
- Medtronic, Inc.
- PMA number
- P200028
- Supplement
- S004
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2021-05-28
- Decision code
- APPR
- Date received
- 2021-03-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of the DiamondTemp Generator Connection Box E (Model: CEDTGCB100) device to the DiamondTemp Ablation System.