PMA supplement
P850010 S082: Helistat Absorbable Collagen Hemostatic Sponge/OraFOAM Absorbable Collagen Hemostatic Sponge
FDA PMA supplement · Normal 180 Day Track No User Fee · Integra LifeSciences Corporation
Key facts
| Original PMA | P850010 |
|---|---|
| Supplement number | S082 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Helistat Absorbable Collagen Hemostatic Sponge/OraFOAM Absorbable Collagen Hemostatic Sponge |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | Integra LifeSciences Corporation |
| Product code | LMF |
| Received date | Sep 14, 2018 |
| Decision date | Mar 13, 2019 |
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: