PMA supplement
N12159 S086: SURGICEL™ Original Absorbable Hemostat, SURGICEL™ NU-KNIT Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat,
FDA PMA supplement · Real-Time Process · ETHICON, Inc.
Key facts
| Original PMA | N12159 |
|---|---|
| Supplement number | S086 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | SURGICEL™ Original Absorbable Hemostat, SURGICEL™ NU-KNIT Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat, |
| Generic name | Agent, absorbable hemostatic, non-collagen based |
| Applicant | ETHICON, Inc. |
| Product code | LMG |
| Received date | Sep 7, 2021 |
| Decision date | Jul 26, 2022 |
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: