COBE CENTRY(R) TPE SYSTEM

FDA Premarket Approval P810023 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

DeviceCOBE CENTRY(R) TPE SYSTEM
Generic NameSeparator, Automated, Blood Cell And Plasma, Therapeutic
ApplicantGAMBRO BCT, INC.
Date Received1993-04-19
Decision Date1994-07-05
PMAP810023
SupplementS002
Product CodeLKN 
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address GAMBRO BCT, INC. 10811 West Collins Ave. lakewood, CO 80215

Supplemental Filings

Supplement NumberDateSupplement Type
P810023Original Filing
S002 1993-04-19 Normal 180 Day Track
S001

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