COOK CHORIONIC VILLUS SAMPLING (CVS) SET

FDA Premarket Approval P900007 S002

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

Approval for a smaller size cvs set (5. 3 fr, 24 cm).

DeviceCOOK CHORIONIC VILLUS SAMPLING (CVS) SET
Generic NameCatheter, Sampling, Chorionic Villus
ApplicantCook Incorporated
Date Received2000-01-04
Decision Date2000-06-12
PMAP900007
SupplementS002
Product CodeLLX 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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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