PMA supplement
P140017 S005: MELODY TRANSCATHETER PULMONARY VALVE, ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM and ENSEMBLE II TRANSCATHETER VALVE D
FDA PMA supplement · Panel Track · Medtronic, Inc.
Key facts
| Original PMA | P140017 |
|---|---|
| Supplement number | S005 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MELODY TRANSCATHETER PULMONARY VALVE, ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM and ENSEMBLE II TRANSCATHETER VALVE D |
| Generic name | Pulmonary valve prosthesis percutaneously delivered |
| Applicant | Medtronic, Inc. |
| Product code | NPV |
| Received date | Sep 1, 2016 |
| Decision date | Feb 24, 2017 |
| Docket number | 17M-1227 |
| Notice date | Mar 10, 2017 |
At a glance
- Yes Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: