PMA supplement
P850057 S006: CUSTOM TINTED HYDROCURVE II HYDROCURVE II APHAKIC, SOFTMATE II AND HC3 TORIC (BUFILCON A)
FDA PMA supplement · Normal 180 Day Track · Ciba Vision Corporation
Key facts
| Original PMA | P850057 |
|---|---|
| Supplement number | S006 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Express GMP Supplement |
| Trade name | CUSTOM TINTED HYDROCURVE II HYDROCURVE II APHAKIC, SOFTMATE II AND HC3 TORIC (BUFILCON A) |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Ciba Vision Corporation |
| Product code | LPM |
| Received date | Dec 23, 1999 |
| Decision date | Sep 18, 2000 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: