PMA supplement
P050038 S030: ARISTA AH ABSORBABLE HEMOSTAT
FDA PMA supplement · Normal 180 Day Track · Davol, Inc.
Key facts
| Original PMA | P050038 |
|---|---|
| Supplement number | S030 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ARISTA AH ABSORBABLE HEMOSTAT |
| Generic name | Agent, absorbable hemostatic, non-collagen based |
| Applicant | Davol, Inc. |
| Product code | LMG |
| Received date | Jun 17, 2016 |
| Decision date | Dec 12, 2016 |
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: