This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | DiamondTemp Ablation System™ with the EnSite™ X Mapping System |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Applicant | Medtronic Inc.8200 Coral Sea Streetmounds View, MN 55112 PMA NumberP200028 Supplement NumberS012 Date Received07/15/2022 Decision Date10/12/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-07-15 |
| Decision Date | 2022-10-12 |
| PMA | P200028 |
| Supplement | S012 |
| Product Code | OAE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Inc. 8200 Coral Sea Street mounds View, MN 55112 PMA NumberP200028 Supplement NumberS012 Date Received07/15/2022 Decision Date10/12/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For Compatibility Of The DiamondTemp Ablation System With The Abbott EnSite X Mapping And Navigation System |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00763000709136 | P200028 | 000 |
| 00763000455699 | P200028 | 000 |
| 00763000512255 | P200028 | 000 |
| 00763000709198 | P200028 | 000 |
| 20763000482163 | P200028 | 000 |
| 00763000482176 | P200028 | 000 |
| 00763000482183 | P200028 | 000 |
| 00763000709150 | P200028 | 000 |
| 00763000482145 | P200028 | 000 |
| 00763000482190 | P200028 | 003 |
| 00763000442842 | P200028 | 004 |
| 00763000482107 | P200028 | 006 |
| 00763000482114 | P200028 | 006 |
| 00763000482121 | P200028 | 006 |
| 00763000482138 | P200028 | 006 |
| 00763000540616 | P200028 | 009 |
| 00763000747121 | P200028 | 012 |
| 00763000747114 | P200028 | 012 |
| 00763000687960 | P200028 | 013 |
| 00763000745516 | P200028 | 016 |
| 00763000745509 | P200028 | 016 |
| 00763000709174 | P200028 | 018 |
| 00763000709181 | P200028 | 018 |
| 20763000687988 | P200028 | 018 |
| 00763000536688 | P200028 | 020 |
| 00763000536671 | P200028 | 020 |