PMA supplement
P820009 S001: LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER
FDA PMA supplement · Normal 180 Day Track · Bausch & Lomb
Key facts
| Original PMA | P820009 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Trade name | LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER |
| Generic name | Catheter, balloon for retinal reattachment |
| Applicant | Bausch & Lomb |
| Product code | LOG |
| Received date | Jun 27, 1985 |
| Decision date | Sep 5, 1985 |
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: