PMA supplement
P980016 S488: EVERA S DR ICD, EVERA S VR ICD; EVERA XT DR. ICD; EVERA XT VR IC D; MAXIMO II ICD; PROTECTA ICD' SECURA ICD, VIRTUOSO II
FDA PMA supplement · 30-Day Notice · Medtronic Cardiac Rhythm Disease Management
Key facts
| Original PMA | P980016 |
|---|---|
| Supplement number | S488 |
| Supplement type | 30-Day Notice |
| Trade name | EVERA S DR ICD, EVERA S VR ICD; EVERA XT DR. ICD; EVERA XT VR IC D; MAXIMO II ICD; PROTECTA ICD' SECURA ICD, VIRTUOSO II |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Product code | LWS |
| Received date | Jun 20, 2014 |
| Decision date | Jul 9, 2014 |
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: