PMA
P880089: AGENASORB
FDA PMA · Powder, dusting, surgical · Intl. Management Services, Inc.
Key facts
| PMA number | P880089 |
|---|---|
| Trade name | AGENASORB |
| Generic name | Powder, dusting, surgical |
| Applicant | Intl. Management Services, Inc. |
| Owner/operator | Stelcore Management Services LLC |
| Product code | KGP |
| Approval date | Sep 13, 1990 |
| Docket number | 90M-0312 |
| Notice date | Oct 23, 1990 |
| Establishment registration | 3013747746 |
| FEI number | 3013747746 |
At a glance
- None Supplements
- Sep 13, 1990 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- No Withdrawn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: