PMA supplement
P150024 S010: AspireAssist
FDA PMA supplement · Normal 180 Day Track No User Fee · Aspire Bariatrics, Inc.
Key facts
| Original PMA | P150024 |
|---|---|
| Supplement number | S010 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | AspireAssist |
| Generic name | Aspiration therapy system |
| Applicant | Aspire Bariatrics, Inc. |
| Product code | OYF |
| Received date | May 1, 2018 |
| Decision date | Jan 15, 2019 |
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: