PMA supplement
N17004 S008: SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
FDA PMA supplement · Real-Time Process · Howmedica Corp.
Key facts
| Original PMA | N17004 |
|---|---|
| Supplement number | S008 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT |
| Generic name | BONE CEMENT |
| Applicant | Howmedica Corp. |
| Product code | LOD |
| Received date | Nov 18, 1996 |
| Decision date | Dec 18, 1996 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: