PMA P200028S002
- Device
- DiamondTemp Ablation System
- Applicant
- Medtronic, Inc.
- Product code
- OAE
- Decision date
- 2021-11-02
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Approval of protocol for the post-approval study (PAS) protocol..
Current openFDA PMA Record#
- Device
- DiamondTemp Ablation System
- Applicant
- Medtronic, Inc.
- PMA number
- P200028
- Supplement
- S002
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2021-11-02
- Decision code
- APPR
- Date received
- 2021-02-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of protocol for the post-approval study (PAS) protocol..