PMA
P990033: PEPGEN P-15
FDA PMA · Bone grafting material, dental, with biologic component · Ceramed Corp.
Key facts
| PMA number | P990033 |
|---|---|
| Trade name | PEPGEN P-15 |
| Generic name | Bone grafting material, dental, with biologic component |
| Applicant | Ceramed Corp. |
| Product code | NPZ |
| Approval date | Oct 25, 1999 |
| Docket number | 99M-4692 |
| Notice date | Nov 4, 1999 |
At a glance
- 10–99 Supplements
- Jul 20, 2010 Latest supplement decision
- Yes Withdrawn
- Yes 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: