PMA
P050031: PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY
FDA PMA · Lens, contact, orthokeratology, overnight · CooperVision, Inc.
Key facts
| PMA number | P050031 |
|---|---|
| Trade name | PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY |
| Generic name | Lens, contact, orthokeratology, overnight |
| Applicant | CooperVision, Inc. |
| Owner/operator | COOPERVISION, INC. |
| Product code | NUU |
| Approval date | Nov 16, 2006 |
| Docket number | 06M-0473 |
| Notice date | Nov 27, 2006 |
| Establishment registration | 1314956 |
| FEI number | 1314956 |
At a glance
- 1–9 Supplements
- May 10, 2022 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: