TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

FDA Premarket Approval P890024 S004

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

• Device: TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER
• Generic Name: Catheter, Sampling, Chorionic Villus
• Applicant: SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
• Date Received: 1991-05-30
• Decision Date: 1992-04-21
• PMA: P890024
• Supplement: S004
• Product Code: LLX
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: Special (immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 Kit St. keene, NH 03431

Supplemental Filings

Supplement Number	Date	Supplement Type
P890024		Original 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