PMA
P030054: ST JUDE MEDICAL EPIC HF SYSTEM
FDA PMA · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) · ABBOTT MEDICAL
Key facts
| PMA number | P030054 |
|---|---|
| Trade name | ST JUDE MEDICAL EPIC HF SYSTEM |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | NIK |
| Approval date | Jun 30, 2004 |
| Docket number | 04M-0313 |
| Notice date | Jul 16, 2004 |
| Establishment registration | 2017865 |
| FEI number | 2017865 |
At a glance
- 100–999 Supplements
- Aug 12, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: