CRYOMAX(TM)

FDA Premarket Approval P820002 S001

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

DeviceCRYOMAX(TM)
Generic NameSeparator, Automated, Blood Cell And Plasma, Therapeutic
ApplicantSTRATO MEDICAL CORP.
Date Received1983-03-15
Decision Date1983-04-26
PMAP820002
SupplementS001
Product CodeLKN 
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
Combination Product No
Applicant Address STRATO MEDICAL CORP. pfizer Hospital Products Group 123 Brimbal Ave beverly, MA 01915

Supplemental Filings

Supplement NumberDateSupplement Type
P820002Original Filing
S002 1983-05-02
S001 1983-03-15

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