PMA supplement
P960040 S467: VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · Boston Scientific
Key facts
| Original PMA | P960040 |
|---|---|
| Supplement number | S467 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Boston Scientific |
| Product code | LWS |
| Received date | Jul 22, 2021 |
| Decision date | Jul 23, 2021 |
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: