PMA supplement
P010031 S381: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES
FDA PMA supplement · Panel Track · Medtronic Cardiac Rhythm Disease Management
Key facts
| Original PMA | P010031 |
|---|---|
| Supplement number | S381 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Product code | NIK |
| Received date | May 29, 2013 |
| Decision date | Apr 10, 2014 |
| Docket number | 14M-0553 |
| Notice date | May 8, 2014 |
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: