PMA
N50163: STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN)
FDA PMA · Susceptibility test powders, antimicrobial · The Upjohn Co.
Key facts
| PMA number | N50163 |
|---|---|
| Trade name | STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN) |
| Generic name | Susceptibility test powders, antimicrobial |
| Applicant | The Upjohn Co. |
| Owner/operator | PFIZER INC. |
| Product code | JTT |
| Approval date | Jul 29, 1970 |
| Establishment registration | 1810189 |
| FEI number | 1810189 |
At a glance
- None Supplements
- Jul 29, 1970 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- No Withdrawn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: