PMA supplement
P820082 S002: THE SOFT LENS THERMAL DISINFECTING UNIT
FDA PMA supplement · THIRTY DAY TRACK · Abbott Medical Optics, Inc.
Key facts
| Original PMA | P820082 |
|---|---|
| Supplement number | S002 |
| Supplement type | THIRTY DAY TRACK |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | THE SOFT LENS THERMAL DISINFECTING UNIT |
| Generic name | Sterilizer, soft-lens, thermal, ac-powered |
| Applicant | Abbott Medical Optics, Inc. |
| Product code | HRD |
| Received date | Jun 25, 1987 |
| Decision date | Jul 31, 1987 |
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: