PMA
P900039: COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE
FDA PMA · Filler, bone void, non-osteoinduction · Neucoll, Inc.
Key facts
| PMA number | P900039 |
|---|---|
| Trade name | COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE |
| Generic name | Filler, bone void, non-osteoinduction |
| Applicant | Neucoll, Inc. |
| Product code | MBS |
| Approval date | May 28, 1993 |
| Docket number | 93M-0210 |
| Notice date | Jul 22, 1993 |
| FEI number | 3003271087 |
At a glance
- 10–99 Supplements
- Jan 24, 2005 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- No Withdrawn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: