PMA supplement
P980016 S681: Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICVD, Primo MRI VR ID, Visia AF MRI
FDA PMA supplement · Normal 180 Day Track No User Fee · Medtronic Cardiac Rhythm Disease Management
Key facts
| Original PMA | P980016 |
|---|---|
| Supplement number | S681 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICVD, Primo MRI VR ID, Visia AF MRI |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Product code | LWS |
| Received date | Jun 28, 2018 |
| Decision date | Oct 3, 2018 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: