PMA
P840049: P.C.A.(TM) TOTAL KNEE SYSTEM
FDA PMA · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER · Howmedica Corp.
Key facts
| PMA number | P840049 |
|---|---|
| Trade name | P.C.A.(TM) TOTAL KNEE SYSTEM |
| Generic name | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
| Applicant | Howmedica Corp. |
| Owner/operator | STRYKER CORP. |
| Product code | HRY |
| Approval date | Sep 30, 1988 |
| Docket number | 88M-0364 |
| Notice date | Dec 16, 1988 |
| Establishment registration | 1811755 |
| FEI number | 1811755 |
At a glance
- 1–9 Supplements
- Sep 10, 1991 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- Yes Withdrawn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: