PMA supplement
P990018 S008: Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear; ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overni
FDA PMA supplement · Normal 180 Day Track · Menicon Co, Ltd.
Key facts
| Original PMA | P990018 |
|---|---|
| Supplement number | S008 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear; ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overni |
| Generic name | Lens, contact, orthokeratology, overnight |
| Applicant | Menicon Co, Ltd. |
| Product code | NUU |
| Received date | Feb 7, 2022 |
| Decision date | Aug 2, 2022 |
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: