PMA supplement
P960040 S028: VENTAK PRIZM AVT AICD SYSTEM
FDA PMA supplement · Panel Track · Boston Scientific
Key facts
| Original PMA | P960040 |
|---|---|
| Supplement number | S028 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | VENTAK PRIZM AVT AICD SYSTEM |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Boston Scientific |
| Product code | LWP |
| Received date | Aug 5, 2002 |
| Decision date | Mar 27, 2003 |
| Docket number | 05M-0435 |
| Notice date | Oct 31, 2005 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: