COOK CHORIONIC VILLUS SAMPLING SET

FDA Premarket Approval P900007 S006

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

Modification to the obturator handle and the technique for affixing it to the obturator wire.

• Device: COOK CHORIONIC VILLUS SAMPLING SET
• Generic Name: Catheter, Sampling, Chorionic Villus
• Applicant: Cook Incorporated
• Date Received: 2008-12-02
• Decision Date: 2009-03-05
• PMA: P900007
• Supplement: S006
• Product Code: LLX
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Cook Incorporated 750 Daniels Way p.o. Box 489 bloomington, IN 47402

Supplemental Filings

Supplement Number	Date	Supplement Type
P900007		Original Filing
S006	2008-12-02	30-day Notice
S005	2008-11-17	Real-time Process
S004	2008-04-01	30-day Notice
S003
S002	2000-01-04	Normal 180 Day Track
S001	1998-01-15	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00827002169081	P900007	001
00827002190276	P900007	002