PMA
BP060001: CryoSeal FS System
FDA PMA · Fibrin sealant preparation device · ThermoGenesis Corp
Key facts
| PMA number | BP060001 |
|---|---|
| Trade name | CryoSeal FS System |
| Generic name | Fibrin sealant preparation device |
| Applicant | ThermoGenesis Corp |
| Owner/operator | Thermogenesis Corp. |
| Product code | CAC |
| Approval date | Jul 26, 2007 |
| Establishment registration | 2950374 |
| FEI number | 1000123765 |
At a glance
- None Supplements
- Jul 26, 2007 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- No Withdrawn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: