Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceSTAN S31 FETAL HEART MONITOR
Generic NameAnalyzer, data, obstetric
Regulation Number884.2050
ApplicantNEOVENTA MEDICAL AB
NORRA AGATAN 32
SE-431 35
MOLNDAL 
PMA NumberP020001
Date Received01/02/2002
Decision Date11/01/2005
Product Code HEO 
Docket Number 06M-0009
Notice Date 01/09/2006
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE STAN S31 FETAL HEART MONITOR. THE DEVICE IS INDICATED 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S004 S005 S006 S007 S008 S009 
-
-