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 | DIAMOND AF |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Applicant | Medtronic Inc.8200 Coral Sea Streetmounds View, MN 55112 PMA NumberP200028 Supplement NumberS014 Date Received10/17/2022 Decision Date11/16/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-10-17 |
| Decision Date | 2022-11-16 |
| PMA | P200028 |
| Supplement | S014 |
| Product Code | OAE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Inc. 8200 Coral Sea Street mounds View, MN 55112 PMA NumberP200028 Supplement NumberS014 Date Received10/17/2022 Decision Date11/16/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For Changes To The Protocol Inclusion And Exclusion Criteria |
| 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 |