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 | Harmony™ Transcatheter Pulmonary Valve |
| Generic Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Applicant | Medtronic, Inc.3576 Unocal Placebuilding Asanta Rosa, CA 95403 PMA NumberP200046 Supplement NumberS008 Date Received03/11/2022 Decision Date04/08/2022 Product Code NPV Advisory Committee Cardiovascular Clinical TrialsNCT02979587 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-03-11 |
| Decision Date | 2022-04-08 |
| PMA | P200046 |
| Supplement | S008 |
| Product Code | NPV |
| 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. 3576 Unocal Place building A santa Rosa, CA 95403 PMA NumberP200046 Supplement NumberS008 Date Received03/11/2022 Decision Date04/08/2022 Product Code NPV Advisory Committee Cardiovascular Clinical TrialsNCT02979587 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval Of The Revised Protocols For The Post-approval Studies. The PAS Protocols Have Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P200046. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200046 | Original Filing | |
| S013 | 2022-11-29 | 30-day Notice |
| S012 | 2022-10-31 | 30-day Notice |
| S011 | 2022-07-26 | 30-day Notice |
| S010 | ||
| S009 | 2022-05-16 | 30-day Notice |
| S008 | 2022-03-11 | Normal 180 Day Track No User Fee |
| S007 | 2022-02-28 | 30-day Notice |
| S006 | 2021-12-02 | 30-day Notice |
| S005 | 2021-07-09 | 30-day Notice |
| S004 | 2021-07-01 | 30-day Notice |
| S003 | ||
| S002 | 2021-04-23 | Special (immediate Track) |
| S001 | 2021-04-05 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00763000341367 | P200046 | 000 |
| 00763000338992 | P200046 | 000 |
| 00763000338985 | P200046 | 000 |