PMA supplement
P870073 S007: MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS
FDA PMA supplement · Normal 180 Day Track · Bausch & Lomb, Inc.
Key facts
| Original PMA | P870073 |
|---|---|
| Supplement number | S007 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS |
| Generic name | Intraocular lens |
| Applicant | Bausch & Lomb, Inc. |
| Product code | HQL |
| Received date | Jan 10, 1992 |
| Decision date | Apr 28, 1993 |
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: