COOK CHORIONIC VILLUS SAMPLING SET

FDA Premarket Approval P900007 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

Change in the sterilization agent used in processing the cook chorionic villus sampling set.

DeviceCOOK CHORIONIC VILLUS SAMPLING SET
Generic NameCatheter, Sampling, Chorionic Villus
ApplicantCook Incorporated
Date Received2008-04-01
Decision Date2008-05-08
PMAP900007
SupplementS004
Product CodeLLX 
Advisory CommitteeObstetrics/Gynecology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Cook Incorporated 750 Daniels Way p.o. Box 489 bloomington, IN 47402

Supplemental Filings

Supplement NumberDateSupplement Type
P900007Original 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 IDPMASupp
00827002169081 P900007 001
00827002190276 P900007 002
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