PMA supplement
P850020 S011: PROSORBA(TM) COLUMN
FDA PMA supplement · Panel Track · Fresenius Hemocare, Inc.
Key facts
| Original PMA | P850020 |
|---|---|
| Supplement number | S011 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PROSORBA(TM) COLUMN |
| Generic name | Separator, automated, blood cell and plasma, therapeutic |
| Applicant | Fresenius Hemocare, Inc. |
| Product code | LKN |
| Received date | Jul 21, 1998 |
| Decision date | Mar 15, 1999 |
| Docket number | 99M-0871 |
| Notice date | Apr 15, 1999 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: