PMA P200028S021

Device: DiamondTemp Ablation System
Applicant: Medtronic, Inc.
Product code: OAE
Decision date: 2023-07-19
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: Transferring the final pack-to-order (PTO) process to a new location due to the closure of existing facility and creating a new automated final functional test for the RF Generator component at the new location.

Current openFDA PMA Record

Device: DiamondTemp Ablation System
Applicant: Medtronic, Inc.
PMA number: P200028
Supplement: S021
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2023-07-19
Decision code: OK30
Date received: 2023-06-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Transferring the final pack-to-order (PTO) process to a new location due to the closure of existing facility and creating a new automated final functional test for the RF Generator component at the new location.