PMA P020001S006

Device: NEOVENTA'S STAN S31 FETAL HEART MONITOR
Applicant: Neoventa Medical AB
PMA number: P020001
Supplement: S006
Product code: HEO
Decision date: 2009-11-16
Generic name: Analyzer, data, obstetric
Approval order statement: APPROVAL FOR CHANGES TO THE CLINICAL GUIDELINES. THE DEVICE ASMODIFIED WILL BE MARKETED UNDER THE TRADE NAME STAN S31 FETAL HEART MONITOR AND 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.THIS DEVICE IS INTENDED FOR USE IN PATIENTS WITH:1) PLANNED VAGINAL DELIVERY;2) >36 COMPLETED WEEKS GESTATION;3) SINGLETON FETUS;4) VERTEX PRESENTATION; AND5) RUPTURED AMNIOTIC MEMBRANES.

Current openFDA PMA Record#

Device: NEOVENTA'S STAN S31 FETAL HEART MONITOR
Applicant: Neoventa Medical AB
PMA number: P020001
Supplement: S006
Product code: HEO
Generic name: Analyzer, data, obstetric
Decision date: 2009-11-16
Decision code: APPR
Date received: 2009-09-11
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE CLINICAL GUIDELINES. THE DEVICE ASMODIFIED WILL BE MARKETED UNDER THE TRADE NAME STAN S31 FETAL HEART MONITOR AND 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.THIS DEVICE IS INTENDED FOR USE IN PATIENTS WITH:1) PLANNED VAGINAL DELIVERY;2) >36 COMPLETED WEEKS GESTATION;3) SINGLETON FETUS;4) VERTEX PRESENTATION; AND5) RUPTURED AMNIOTIC MEMBRANES.