PMA supplement
P010031 S540: Amplia MRI SureScan Model DTMB1D4, Amplia MRI Quad SureScan Model DTMB1QQ, Compia MRI SureScan Model DTMC1D4, Compia MR
FDA PMA supplement · Normal 180 Day Track · Medtronic Cardiac Rhythm Disease Management
Key facts
| Original PMA | P010031 |
|---|---|
| Supplement number | S540 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Amplia MRI SureScan Model DTMB1D4, Amplia MRI Quad SureScan Model DTMB1QQ, Compia MRI SureScan Model DTMC1D4, Compia MR |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Product code | NIK |
| Received date | Mar 11, 2016 |
| Decision date | Sep 7, 2016 |
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: