PMA supplement
P950022 S149: Durata 7120, 7121, 7122, 7130, 7131, 7170, 7171, 7120, 7120Q, 7121Q, 7122, 7122Q, 7170Q, 7171Q, 7172Q; Optisure LDA210,
FDA PMA supplement · 30-Day Notice · ABBOTT MEDICAL
Key facts
| Original PMA | P950022 |
|---|---|
| Supplement number | S149 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Durata 7120, 7121, 7122, 7130, 7131, 7170, 7171, 7120, 7120Q, 7121Q, 7122, 7122Q, 7170Q, 7171Q, 7172Q; Optisure LDA210, |
| Applicant | ABBOTT MEDICAL |
| Received date | May 29, 2025 |
| Decision date | Jun 18, 2025 |
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: