PMA supplement
P860040 S016: BIOCURVE SOFT CONTACT LENSES
FDA PMA supplement · Normal 180 Day Track No User Fee · Wavetouch Technologies, LLC
Key facts
| Original PMA | P860040 |
|---|---|
| Supplement number | S016 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Express GMP Supplement |
| Trade name | BIOCURVE SOFT CONTACT LENSES |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Wavetouch Technologies, LLC |
| Product code | LPM |
| Received date | May 5, 2004 |
| Decision date | May 28, 2004 |
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: