PMA supplement
BP830014 S010: Abbott Corzyme-M (rDNA)
FDA PMA supplement · 30-Day Notice · Abbott Laboratories
Key facts
| Original PMA | BP830014 |
|---|---|
| Supplement number | S010 |
| Supplement type | 30-Day Notice |
| Trade name | Abbott Corzyme-M (rDNA) |
| Generic name | Identification system for hepatitis b antigen |
| Applicant | Abbott Laboratories |
| Product code | KSJ |
| Received date | Dec 29, 2004 |
| Decision date | Jan 27, 2005 |
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: