PMA
P890061: VENTAK P 1600 AICD AND 2830 SOFTWARE MODULE
FDA PMA · Implantable cardioverter defibrillator (non-CRT) · Boston Scientific
Key facts
| PMA number | P890061 |
|---|---|
| Trade name | VENTAK P 1600 AICD AND 2830 SOFTWARE MODULE |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Boston Scientific |
| Owner/operator | Boston Scientific Corporation |
| Product code | LWS |
| Approval date | May 2, 1991 |
| Docket number | 91M-0184 |
| Notice date | Jun 13, 1991 |
| Establishment registration | 2124215 |
| FEI number | 2124215 |
At a glance
- 10–99 Supplements
- Apr 2, 2021 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: