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Device | STAN S31 FETAL HEART MONITOR |
Generic Name | Analyzer, data, obstetric |
Regulation Number | 884.2050 |
Applicant | NEOVENTA MEDICAL AB NORRA AGATAN 32 SE-431 35 MOLNDAL |
PMA Number | P020001 |
Supplement Number | S002 |
Date Received | 08/13/2007 |
Decision Date | 09/26/2007 |
Product Code |
HEO |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE LCD PANEL MODEL, POWER SUPPLY UNIT, AND ADDITION OF AN INTERNAL FAN. THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO FETAL HEART RATE MONITORING TO DETERMINE WHETHER OBSTETRICAL INTERVENTION IS WARRANTED WHEN THERE IS INCREASED RISK OF DEVELOPING METABOLIC ACIDOSIS. THE DEVICE IS INTENDED FOR USE IN PATIENTS WITH: 1) PLANNED VAGINAL DELIVERY; 2) >36 COMPLETED WEEKS GESTATION; 3) SINGLETON FETUS; 4) VERTEX PRESENTATION; AND 5) RUPTURED AMNIOTIC MEMBRANES. |