PMA supplement
P990026 S008: GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER
FDA PMA supplement · Panel Track · Animas Corp.
Key facts
| Original PMA | P990026 |
|---|---|
| Supplement number | S008 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER |
| Generic name | GLUCOSE OXIDASE, GLUCOSE |
| Applicant | Animas Corp. |
| Product code | CGA |
| Received date | Sep 19, 2001 |
| Decision date | Aug 26, 2002 |
| Docket number | 02M-0412 |
| Notice date | Sep 16, 2002 |
At a glance
- Yes 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: