PMA supplement
P000009 S064: BELOS DR/DR-T/VR-VR-T LEXOS DR/DR-T/VR-VR-T; LUMOS DR-T/VR-T; XELOS DR-T
FDA PMA supplement · Real-Time Process · Biotronik, Inc.
Key facts
| Original PMA | P000009 |
|---|---|
| Supplement number | S064 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | BELOS DR/DR-T/VR-VR-T LEXOS DR/DR-T/VR-VR-T; LUMOS DR-T/VR-T; XELOS DR-T |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Applicant | Biotronik, Inc. |
| Product code | NIK |
| Received date | Dec 16, 2015 |
| Decision date | Apr 13, 2016 |
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: