PMA supplement
P010015 S205: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES
FDA PMA supplement · Panel Track · Medtronic, Inc.
Key facts
| Original PMA | P010015 |
|---|---|
| Supplement number | S205 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES |
| Generic name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
| Applicant | Medtronic, Inc. |
| Product code | NKE |
| 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: