PMA P200028S026

Device: DiamondTemp Ablation System
Applicant: Medtronic, Inc.
PMA number: P200028
Supplement: S026
Product code: OAE
Decision date: 2025-10-10
Classification: Cardiovascular
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P200028.

Current openFDA PMA Record#

Device: DiamondTemp Ablation System
Applicant: Medtronic, Inc.
PMA number: P200028
Supplement: S026
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2025-10-10
Decision code: APPR
Date received: 2025-07-01
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P200028.