PMA supplement
P000016 S002: COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING
FDA PMA supplement · Special (Immediate Track) · Ge Medical Systems Information Technologies
Key facts
| Original PMA | P000016 |
|---|---|
| Supplement number | S002 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING |
| Generic name | Oximeter, fetal pulse |
| Applicant | Ge Medical Systems Information Technologies |
| Product code | MMA |
| Received date | Sep 15, 2003 |
| Decision date | Oct 15, 2003 |
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: