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 |
Generic Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
Applicant | MEDTRONIC Inc.8200 Coral Sea Street Nemvs83mounds View, MN 55112 PMA NumberP140017 Supplement NumberS022 Date Received07/20/2022 Decision Date08/03/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-07-20 |
Decision Date | 2022-08-03 |
PMA | P140017 |
Supplement | S022 |
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 NumberS022 Date Received07/20/2022 Decision Date08/03/2022 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 re-validation Of An Existing Cleanroom |
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 |