|
Device | Melody TPV System |
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 | S011 |
Date Received | 09/26/2018 |
Decision Date | 10/30/2018 |
Product Code |
NPV |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a dimensional change to the Platinum-Iridium marker bands on the Ensemble II Transcatheter Valve Delivery System. |