PMA supplement
P830045 S081: ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND B-235)
FDA PMA supplement · Real-Time Process · St. Jude Medical, Inc.
Key facts
| Original PMA | P830045 |
|---|---|
| Supplement number | S081 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND B-235) |
| Generic name | Programmer, pacemaker |
| Applicant | St. Jude Medical, Inc. |
| Product code | KRG |
| Received date | Jul 17, 2002 |
| Decision date | Jul 30, 2002 |
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: