PMA
P080009: SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
FDA PMA · Computer-assisted personalized sedation system · Scott Laboratories, Inc.
Key facts
| PMA number | P080009 |
|---|---|
| Trade name | SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM |
| Generic name | Computer-assisted personalized sedation system |
| Applicant | Scott Laboratories, Inc. |
| Product code | PDR |
| Approval date | May 3, 2013 |
| Docket number | 13M-0549 |
| Notice date | May 8, 2013 |
| FEI number | 3004113249 |
At a glance
- 10–99 Supplements
- Mar 15, 2016 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: