Approval for the diamondtemp catheter is indicated for use in cardiac electrophysiological mapping(stimulation and recording) and for treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation when used in conjunction with the diamondtemp rf generator and accessories (diamondtemp catheter-to-rf generator cable, diamondtemp genconnect cable, diamondtemp egm cable, diamondtemp irrigation pump, diamondtemp irrigation tubing set) and compatible mapping system.
| Device | DiamondTemp Ablation System |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Applicant | Medtronic Inc. |
| Date Received | 2020-06-15 |
| Decision Date | 2021-01-28 |
| PMA | P200028 |
| Supplement | S |
| Product Code | OAE |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Inc. 8200 Coral Sea Street mounds View, MN 55112 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P200028 | | Original Filing |
| S014 |
2022-10-17 |
Normal 180 Day Track No User Fee |
| S013 | | |
| S012 |
2022-07-15 |
Real-time Process |
| S011 |
2022-05-16 |
30-day Notice |
| S010 |
2022-02-04 |
30-day Notice |
| S009 | | |
| S008 | | |
| S007 |
2021-09-27 |
30-day Notice |
| S006 |
2021-04-20 |
Special (immediate Track) |
| S005 | | |
| S004 | | |
| S003 | | |
| S002 | | |
| S001 |
2021-02-08 |
30-day Notice |
NIH GUDID Devices