PMA
P150024: AspireAssist
FDA PMA · Aspiration therapy system · Aspire Bariatrics, Inc.
Key facts
| PMA number | P150024 |
|---|---|
| Trade name | AspireAssist |
| Generic name | Aspiration therapy system |
| Applicant | Aspire Bariatrics, Inc. |
| Product code | OYF |
| Approval date | Jun 14, 2016 |
| Docket number | 16m-1754 |
| Notice date | Jun 14, 2016 |
| FEI number | 3009595931 |
At a glance
- 10–99 Supplements
- Apr 24, 2020 Latest supplement decision
- Yes Withdrawn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: