PMA
N50061: POLYMYXIN B SULFATE SUSCEPTIBILITY TESTING
FDA PMA · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION · Pfizer, Inc.
Key facts
| PMA number | N50061 |
|---|---|
| Trade name | POLYMYXIN B SULFATE SUSCEPTIBILITY TESTING |
| Generic name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
| Applicant | Pfizer, Inc. |
| Owner/operator | PFIZER INC. |
| Product code | LON |
| Approval date | Nov 24, 1969 |
| Establishment registration | 3009712172 |
| FEI number | 3009712172 |
At a glance
- None Supplements
- Nov 24, 1969 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- No Withdrawn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: