| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR |
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| Generic Name | Oximeter, fetal pulse |
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| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8880 GORMAN ROAD
LAUREL, MD 20723 |
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| PMA Number | P000016 |
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| Date Received | 04/05/2000 |
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| Decision Date | 02/09/2001 |
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Withdrawal Date
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09/12/2007 |
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| Product Code |
MMA |
| Docket Number | 01M-0329 |
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| Notice Date | 08/02/2001 |
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| Advisory Committee |
Obstetrics/Gynecology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITN INTEGRATED FETAL OXYGEN SATURATION MONITORING, COROMETRICS FETAL PATIENT MOFULE, AND THE NELLCOR OXIFIRST(TM) FS14 SENSOR. THE 120 F-SERIES SYSTEM CONTINUOUSLY MONITORS INTRAPARTUM FETAL OXYGEN SATURATION (FSPO2) AND IS INDICATED AS AN ADJUNCT TO FETAL HEART RATE (FHR) MONITORING IN THE PRESENCE OF A NONREASSURING FETAL HEART RATE PATTERN. IT SHOULD ONLY BE USED AFTER MATERNAL MEMBRANES HAVE RUPTURED AND ON A SINGLETON FETUS IN VERTEX PRESENTATION WITH A GESTATIONAL AGE GREATER THAN OR EQUAL TO 36 WEEKS. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 |
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