PMA supplement
P870024 S043: PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..
FDA PMA supplement · Panel Track · CooperVision, Inc.
Key facts
| Original PMA | P870024 |
|---|---|
| Supplement number | S043 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100.. |
| Generic name | Lens, contact, orthokeratology, overnight |
| Applicant | CooperVision, Inc. |
| Product code | NUU |
| Received date | Oct 2, 2001 |
| Decision date | Jun 13, 2002 |
| Docket number | 02M-0295 |
| Notice date | Jul 2, 2002 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: