PMA P200028S005
- Device
- DiamondTemp Ablation System
- Applicant
- Medtronic, Inc.
- Product code
- OAE
- Decision date
- 2021-06-02
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Approval for design and manufacturing process changes for the Bidirectional DiamondTemp Ablation Catheters.
Current openFDA PMA Record#
- Device
- DiamondTemp Ablation System
- Applicant
- Medtronic, Inc.
- PMA number
- P200028
- Supplement
- S005
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2021-06-02
- Decision code
- APPR
- Date received
- 2021-03-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design and manufacturing process changes for the Bidirectional DiamondTemp Ablation Catheters.