PMA
P820009: LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER
FDA PMA · Catheter, balloon for retinal reattachment · Bausch & Lomb
Key facts
| PMA number | P820009 |
|---|---|
| Trade name | LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER |
| Generic name | Catheter, balloon for retinal reattachment |
| Applicant | Bausch & Lomb |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | LOG |
| Approval date | Oct 25, 1983 |
| Docket number | 83M-0370 |
| Notice date | Nov 21, 1983 |
| Establishment registration | 1281950 |
| FEI number | 1281950 |
At a glance
- 1–9 Supplements
- Sep 18, 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- Yes Withdrawn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: