PMA
P820086: CIBATINT(TM) TINTING PROCESS
FDA PMA · Lenses, soft contact, extended wear · Ciba Vision Care
Key facts
| PMA number | P820086 |
|---|---|
| Trade name | CIBATINT(TM) TINTING PROCESS |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Ciba Vision Care |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | LPM |
| Approval date | Feb 8, 1984 |
| Docket number | 84M-0091 |
| Notice date | Apr 10, 1984 |
| Establishment registration | 9610813 |
| FEI number | 1030321 |
At a glance
- 10–99 Supplements
- Nov 23, 1993 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- Yes Withdrawn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: