PMA supplement
P990026 S007: GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
FDA PMA supplement · Normal 180 Day Track · Animas Corp.
Key facts
| Original PMA | P990026 |
|---|---|
| Supplement number | S007 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Express GMP Supplement |
| Trade name | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER |
| Generic name | GLUCOSE OXIDASE, GLUCOSE |
| Applicant | Animas Corp. |
| Product code | CGA |
| Received date | Aug 28, 2001 |
| Decision date | Oct 25, 2001 |
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: