PMA
P800064: BIOFLOW(TM)
FDA PMA · Graft, vascular, hemodialysis access, synthetic/biological composite · Genetic Laboratories, Inc.
Key facts
| PMA number | P800064 |
|---|---|
| Trade name | BIOFLOW(TM) |
| Generic name | Graft, vascular, hemodialysis access, synthetic/biological composite |
| Applicant | Genetic Laboratories, Inc. |
| Owner/operator | Myriad Genetic Laboratories, Inc. |
| Product code | MCI |
| Approval date | Mar 10, 1982 |
| Docket number | 82M-0094 |
| Notice date | Jul 20, 1982 |
| Establishment registration | 3030654068 |
| FEI number | 3030654068 |
At a glance
- None Supplements
- Mar 10, 1982 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- No Withdrawn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: