PMA supplement
P980040 S077: TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOLS) EXTENDED CYLINDER RANGE (ECR), MODELS ZCT450, ZCT525 AND ZCT600
FDA PMA supplement · Normal 180 Day Track No User Fee · Johnson & Johnson Surgical Vision, Inc.
Key facts
| Original PMA | P980040 |
|---|---|
| Supplement number | S077 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol - OSB |
| Trade name | TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOLS) EXTENDED CYLINDER RANGE (ECR), MODELS ZCT450, ZCT525 AND ZCT600 |
| Generic name | Intraocular lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Product code | HQL |
| Received date | Jan 5, 2017 |
| Decision date | Mar 3, 2017 |
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: