PMA
P820002: CRYOMAX(TM)
FDA PMA · Separator, automated, blood cell and plasma, therapeutic · Strato Medical Corp.
Key facts
| PMA number | P820002 |
|---|---|
| Trade name | CRYOMAX(TM) |
| Generic name | Separator, automated, blood cell and plasma, therapeutic |
| Applicant | Strato Medical Corp. |
| Product code | LKN |
| Approval date | Jan 31, 1983 |
| Docket number | 83M-0039 |
| Notice date | Feb 18, 1983 |
At a glance
- 1–9 Supplements
- Aug 3, 1983 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- No Withdrawn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: