|
Device | ENSEMBLE II TRANSCATHETER VALVE DELIVERY 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 | S004 |
Date Received | 04/25/2016 |
Decision Date | 09/12/2016 |
Product Code |
NPV |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a product line extension to the Ensemble Transcatheter Valve Delivery System. |