- Device
- DiamondTemp Ablation System
- Applicant
- Medtronic, Inc.
- PMA number
- P200028
- Supplement
- S009
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2022-05-02
- Decision code
- APPR
- Date received
- 2022-02-02
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the DiamondTemp Irrigation Pump user manual, including a new flow rate verification procedure.