Changes in the bioburden sampling plan and an expansion in the number of sterilization chambers and pallets
| Device | DiamondTemp Ablation System |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Applicant | Medtronic Inc. |
| Date Received | 2021-09-27 |
| Decision Date | 2021-10-27 |
| PMA | P200028 |
| Supplement | S007 |
| Product Code | OAE |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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