TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

FDA Premarket Approval P890024 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceTROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER
Generic NameCatheter, Sampling, Chorionic Villus
ApplicantSMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
Date Received1992-05-04
Decision Date1993-12-27
PMAP890024
SupplementS005
Product CodeLLX 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 Kit St. keene, NH 03431

Supplemental Filings

Supplement NumberDateSupplement Type
P890024Original Filing
S005 1992-05-04 Normal 180 Day Track
S004 1991-05-30 Special (immediate Track)
S003 1991-05-28 Normal 180 Day Track
S002 1990-08-28 Normal 180 Day Track
S001 1990-08-14 Normal 180 Day Track

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.