PMA
P990050: OPTICAL BIOPSY(TM) SYSTEM
FDA PMA · ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON) · Spectra Science
Key facts
| PMA number | P990050 |
|---|---|
| Trade name | OPTICAL BIOPSY(TM) SYSTEM |
| Generic name | ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON) |
| Applicant | Spectra Science |
| Product code | MOA |
| Approval date | Nov 14, 2000 |
| Docket number | 01M-0478 |
| Notice date | Oct 19, 2001 |
At a glance
- 1–9 Supplements
- Aug 27, 2009 Latest supplement decision
- No Withdrawn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: