PMA supplement
P800016 S006: TENNANT(TM) & KELMAN(TM) TYPE II
FDA PMA supplement · Bausch & Lomb, Inc.
Key facts
| Original PMA | P800016 |
|---|---|
| Supplement number | S006 |
| Trade name | TENNANT(TM) & KELMAN(TM) TYPE II |
| Generic name | Transducer, ultrasonic, obstetric |
| Applicant | Bausch & Lomb, Inc. |
| Product code | HGL |
| Received date | Dec 10, 1985 |
| Decision date | Jan 8, 1986 |
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: