PMA supplement
P010018 S005: VIEWPOINT CK SYSTEM
FDA PMA supplement · Panel Track · Refractec, Inc.
Key facts
| Original PMA | P010018 |
|---|---|
| Supplement number | S005 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | VIEWPOINT CK SYSTEM |
| Generic name | Electrosurgical, radio frequency, refractive correction |
| Applicant | Refractec, Inc. |
| Product code | MWD |
| Received date | Aug 27, 2003 |
| Decision date | Mar 16, 2004 |
| Docket number | 04M-0134 |
| Notice date | Mar 23, 2004 |
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: