Food and Drug Administration

Obstetrics and Gynecology Devices Panel

April 22, 2002

Neoventa STAN S21 Fetal Heart Monitor (P020001)

Briefing Information

Sponsor - Neoventa, Inc.

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Cover Letter - Introduction  pdf

Bibliographic Listing   pdf

Summary of Safety and Effectiveness   pdf

Device Description  pdf

Swedish Randomized Controlled Trial (RCT), Revised 02/18/02   pdf

Swedish Randomized Controlled Trial (RCT), Final Version, 05/05/98   pdf

Neonatal outcome in the CTG group   pdf

Neonatal outcome in the CTG+ST group   pdf

Cases of metabolic acidosis in CTG group not requiring special neonatal care - ST information revealed   pdf

Cases of metabolic acidosis in CTG_ST group not requiring special neonatal case   pdf

Dissemination of Knowledge, Centers of Excellance Program   pdf

Summary of the STANŽ S 21 clinical database - data from the city of Gothenburg   pdf

Summary Chart of Prior Clinical Studies   pdf

Note:  This brief package contained copyrighted material which may be view at:  Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD  20852.