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 | Melody™ Transcatheter Pulmonary Valve System |
| Generic Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Applicant | MEDTRONIC Inc.8200 Coral Sea Street Nemvs83mounds View, MN 55112 PMA NumberP140017 Supplement NumberS021 Date Received02/28/2022 Decision Date03/01/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-28 |
| Decision Date | 2022-03-01 |
| PMA | P140017 |
| Supplement | S021 |
| Product Code | NPV |
| 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 Ne mvs83 mounds View, MN 55112 PMA NumberP140017 Supplement NumberS021 Date Received02/28/2022 Decision Date03/01/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement use Of A New Data Management System For Microbiology Laboratory Test Data And Data Reporting At The Medtronic Tijuana Facility For The Evolut R, Evolut PRO, Evolut PRO+, And Evolut FX Transcatheter Aortic Valves (TAVs), Harmony And Melody Transcatheter Pulmonic Valves (TPV), And Avalus Bioprosthesis Products |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140017 | Original Filing | |
| S023 | 2022-11-16 | 30-day Notice |
| S022 | 2022-07-20 | 30-day Notice |
| S021 | 2022-02-28 | 30-day Notice |
| S020 | 2022-01-27 | 30-day Notice |
| S019 | 2021-07-29 | 30-day Notice |
| S018 | ||
| S017 | 2019-10-01 | 30-day Notice |
| S016 | ||
| S015 | 2019-06-20 | 30-day Notice |
| S014 | 2018-11-13 | Normal 180 Day Track No User Fee |
| S013 | ||
| S012 | 2018-10-01 | 30-day Notice |
| S011 | 2018-09-26 | Real-time Process |
| S010 | 2017-12-01 | 30-day Notice |
| S009 | ||
| S008 | 2017-09-11 | 30-day Notice |
| S007 | 2017-04-19 | 30-day Notice |
| S006 | 2016-11-23 | Normal 180 Day Track No User Fee |
| S005 | 2016-09-01 | Panel Track |
| S004 | 2016-04-25 | Normal 180 Day Track |
| S003 | 2016-04-08 | 30-day Notice |
| S002 | 2016-03-23 | 30-day Notice |
| S001 | 2015-06-17 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00643169588455 | P140017 | 000 |
| 00643169588448 | P140017 | 000 |
| 00643169588431 | P140017 | 000 |
| 00643169588196 | P140017 | 000 |
| 00643169588189 | P140017 | 000 |
| 00643169713895 | P140017 | 004 |
| 00643169713901 | P140017 | 004 |
| 00643169713888 | P140017 | 004 |