PMA
P820032: PLASMA SEPARATION SYSTEM
FDA PMA · CERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES · Fenwal, Inc.
Key facts
| PMA number | P820032 |
|---|---|
| Trade name | PLASMA SEPARATION SYSTEM |
| Generic name | CERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES |
| Applicant | Fenwal, Inc. |
| Owner/operator | Fresenius Kabi AG |
| Product code | LMN |
| Approval date | Oct 7, 1983 |
| Docket number | 83M-0352 |
| Notice date | Nov 3, 1983 |
| Establishment registration | 3004548776 |
| FEI number | 3004548776 |
At a glance
- 1–9 Supplements
- Aug 25, 1987 Latest supplement decision
- Yes Withdrawn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: