PMA supplement
P850001 S007: HORIZON(TM) YAG LASER MODEL 2000
FDA PMA supplement · Normal 180 Day Track · CooperVision, Inc.
Key facts
| Original PMA | P850001 |
|---|---|
| Supplement number | S007 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | HORIZON(TM) YAG LASER MODEL 2000 |
| Generic name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
| Applicant | CooperVision, Inc. |
| Product code | LOI |
| Received date | Sep 16, 1986 |
| Decision date | Apr 20, 1987 |
| Docket number | 87M-0158 |
| Notice date | Jun 8, 1987 |
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: