PMA
P870013: IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR
FDA PMA · Intraocular lens · Bausch & Lomb
Key facts
| PMA number | P870013 |
|---|---|
| Trade name | IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR |
| Generic name | Intraocular lens |
| Applicant | Bausch & Lomb |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | HQL |
| Approval date | Mar 31, 1988 |
| Docket number | 88M-0159 |
| Notice date | Jul 20, 1988 |
| Establishment registration | 1313525 |
| FEI number | 1317628 |
At a glance
- 10–99 Supplements
- Aug 13, 2003 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- Yes Withdrawn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: