PMA
P880028: DEXTRAN HM 32%
FDA PMA · FLUID, HYSTEROSCOPY · Hospira, Inc.
Key facts
| PMA number | P880028 |
|---|---|
| Trade name | DEXTRAN HM 32% |
| Generic name | FLUID, HYSTEROSCOPY |
| Applicant | Hospira, Inc. |
| Owner/operator | PFIZER INC. |
| Product code | LTA |
| Approval date | May 30, 1989 |
| Docket number | 89M-0194 |
| Notice date | Jun 29, 1989 |
| Establishment registration | 1925262 |
| FEI number | 1925262 |
At a glance
- 1–9 Supplements
- Jan 29, 1999 Latest supplement decision
- Yes Withdrawn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: