PMA supplement
P030054 S010: EPIC AND ATLAS+ HF CRT-D SYSTEMS
FDA PMA supplement · Panel Track · ABBOTT MEDICAL
Key facts
| Original PMA | P030054 |
|---|---|
| Supplement number | S010 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | EPIC AND ATLAS+ HF CRT-D SYSTEMS |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Applicant | ABBOTT MEDICAL |
| Product code | NIK |
| Received date | Jun 6, 2005 |
| Decision date | Nov 18, 2005 |
| Docket number | 05M-0492 |
| Notice date | Dec 19, 2005 |
At a glance
- No 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: