PMA supplement
P990004 S019: SURGIFOAM HEMOSTATIC MATRIX AND SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN
FDA PMA supplement · Normal 180 Day Track · Ferrosan Meidcal Devices A/S
Key facts
| Original PMA | P990004 |
|---|---|
| Supplement number | S019 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | SURGIFOAM HEMOSTATIC MATRIX AND SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | Ferrosan Meidcal Devices A/S |
| Product code | LMF |
| Received date | Oct 18, 2010 |
| Decision date | May 17, 2011 |
At a glance
- No Expedited review granted
- Yes 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: