PMA
P860012: ALVEOFORM TM BIOGRAFT
FDA PMA · Implant, endosseous, root-form · Collagen Corp.
Key facts
| PMA number | P860012 |
|---|---|
| Trade name | ALVEOFORM TM BIOGRAFT |
| Generic name | Implant, endosseous, root-form |
| Applicant | Collagen Corp. |
| Owner/operator | COLLAGEN MATRIX, INC. |
| Product code | DZE |
| Approval date | Oct 28, 1988 |
| Docket number | 89M-0003 |
| Notice date | Feb 15, 1989 |
| Establishment registration | 3003300673 |
| FEI number | 3003300673 |
At a glance
- 1–9 Supplements
- Mar 21, 1995 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- No Withdrawn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: