PMA supplement
P980016 S543: EVERA S DR,SVR, XT DR.XT VR ICD'S; MAXIMO II ICD, PROTECTA ICD & XT ICD; SECURA ICD, VIRTUOSO II DR/VR ICD
FDA PMA supplement · 30-Day Notice · Medtronic Cardiac Rhythm Disease Management
Key facts
| Original PMA | P980016 |
|---|---|
| Supplement number | S543 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | EVERA S DR,SVR, XT DR.XT VR ICD'S; MAXIMO II ICD, PROTECTA ICD & XT ICD; SECURA ICD, VIRTUOSO II DR/VR ICD |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Product code | LWS |
| Received date | Jul 24, 2015 |
| Decision date | Aug 20, 2015 |
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: