|
Device | Melody Transcatheter Pulmonary Valve |
Generic Name | Pulmonary valve prosthesis percutaneously delivered |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MVS83 MOUNDS VIEW, MN 55112 |
PMA Number | P140017 |
Supplement Number | S029 |
Date Received | 02/08/2024 |
Decision Date | 03/08/2024 |
Product Code |
NPV |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement implementation of test methods for additional microorganism detection and enumeration during pre-sterilization bioburden assessments |