PMA supplement
P780002 S012: DARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT
FDA PMA supplement · Normal 180 Day Track · Synovis Surgical Innovations
Key facts
| Original PMA | P780002 |
|---|---|
| Supplement number | S012 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | DARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT |
| Generic name | Tissue graft of 6mm and greater |
| Applicant | Synovis Surgical Innovations |
| Product code | LXA |
| Received date | Sep 8, 1995 |
| Decision date | Nov 24, 1995 |
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: