PLASMA SEPARATION SYSTEM

FDA Premarket Approval P820032 S003

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

DevicePLASMA SEPARATION SYSTEM
Generic NameSeparator, Automated, Blood Cell And Plasma, Therapeutic
ApplicantFENWAL, INC.
Date Received1984-05-07
Decision Date1984-06-13
PMAP820032
SupplementS003
Product CodeLKN 
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
Combination Product No
Applicant Address FENWAL, INC. three Corporate Drive lake Zurich, IL 60047

Supplemental Filings

Supplement NumberDateSupplement Type
P820032Original Filing
S005 1987-07-07 Normal 180 Day Track
S004 1985-06-07
S003 1984-05-07
S002 1984-04-30
S001 1983-11-22

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