PMA P020001S002

Device: STAN S31 FETAL HEART MONITOR
Applicant: Neoventa Medical AB
PMA number: P020001
Supplement: S002
Product code: HEO
Decision date: 2007-09-26
Generic name: Analyzer, data, obstetric
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.

Current openFDA PMA Record#

Device: STAN S31 FETAL HEART MONITOR
Applicant: Neoventa Medical AB
PMA number: P020001
Supplement: S002
Product code: HEO
Generic name: Analyzer, data, obstetric
Decision date: 2007-09-26
Decision code: APPR
Date received: 2007-08-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.