PMA
P990026: GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
FDA PMA · INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY · Animas Corp.
Key facts
| PMA number | P990026 |
|---|---|
| Trade name | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER |
| Generic name | INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY |
| Applicant | Animas Corp. |
| Owner/operator | HAVPAK, INC. |
| Product code | NCT |
| Approval date | Mar 22, 2001 |
| Docket number | 01M-0371 |
| Notice date | Aug 29, 2001 |
| Establishment registration | 3017125080 |
| FEI number | 3017125080 |
At a glance
- 10–99 Supplements
- Jun 22, 2004 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: