PMA
P050011: ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION
FDA PMA · Barrier, absorbable, adhesion · Baxter Healthcare Corp
Key facts
| PMA number | P050011 |
|---|---|
| Trade name | ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION |
| Generic name | Barrier, absorbable, adhesion |
| Applicant | Baxter Healthcare Corp |
| Owner/operator | BAXTER HEALTHCARE CORPORATION |
| Product code | MCN |
| Approval date | Jul 28, 2006 |
| Docket number | 06M-0322 |
| Notice date | Aug 17, 2006 |
| Establishment registration | 1416980 |
| FEI number | 1416980 |
At a glance
- 10–99 Supplements
- Aug 23, 2024 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: