PMA
P850063: MICRO YAG ND:YAG LASER SYSTEM
FDA PMA · Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary · Sorin Group USA, Inc.
Key facts
| PMA number | P850063 |
|---|---|
| Trade name | MICRO YAG ND:YAG LASER SYSTEM |
| Generic name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
| Applicant | Sorin Group USA, Inc. |
| Owner/operator | LivaNova |
| Product code | LOI |
| Approval date | Jan 31, 1986 |
| Docket number | 86M-0107 |
| Notice date | May 30, 1986 |
| Establishment registration | 1718850 |
| FEI number | 1718850 |
At a glance
- 1–9 Supplements
- Jun 17, 1986 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: