PMA supplement
P860035 S004: TITRATOR{TM} MODEL 10K
FDA PMA supplement · Normal 180 Day Track · Ivac Corporation
Key facts
| Original PMA | P860035 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | TITRATOR{TM} MODEL 10K |
| Generic name | CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE |
| Applicant | Ivac Corporation |
| Product code | LSX |
| Received date | Sep 20, 1990 |
| Decision date | Dec 28, 1990 |
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: