PMA supplement
P000009 S025: LUMOS VR/DR (-T) AND LEXOS DR/VR (-T) ICD'S
FDA PMA supplement · Real-Time Process · Biotronik, Inc.
Key facts
| Original PMA | P000009 |
|---|---|
| Supplement number | S025 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | LUMOS VR/DR (-T) AND LEXOS DR/VR (-T) ICD'S |
| Generic name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
| Applicant | Biotronik, Inc. |
| Product code | MRM |
| Received date | Jan 15, 2008 |
| Decision date | Mar 10, 2008 |
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: