PMA supplement
N6264 S003: BIO-SORB ABSORBABLE DUSTING POWDER
FDA PMA supplement · Johnson & Johnson Medical, Inc.
Key facts
| Original PMA | N6264 |
|---|---|
| Supplement number | S003 |
| Trade name | BIO-SORB ABSORBABLE DUSTING POWDER |
| Generic name | Powder, dusting, surgical |
| Applicant | Johnson & Johnson Medical, Inc. |
| Product code | KGP |
| Received date | Aug 21, 1985 |
| Decision date | Sep 10, 1985 |
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: