PMA
P960034: CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT.
FDA PMA · Abbott Medical Optics, Inc.
Key facts
| PMA number | P960034 |
|---|---|
| Trade name | CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT. |
| Applicant | Abbott Medical Optics, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Approval date | Aug 12, 1998 |
| Docket number | 98M-0725 |
| Notice date | Oct 27, 1998 |
| Establishment registration | 3004936110 |
| FEI number | 3004936110 |
At a glance
- 1–9 Supplements
- May 8, 2007 Latest supplement decision
- Yes Withdrawn
- No 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: