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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
Classification Namecontrast media, ultrasound
Generic Namealbumin ultrasound contrast microspheres
ApplicantMOLECULAR BIOSYSTEMS, INC.
PMA NumberP900059
Supplement NumberS003
Date Received06/05/1995
Decision Date08/28/1995
Product Code
MJS
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for release of final product based on results from kinetic quantitative chromogenic lal baterial endotoxin test and replacement of taii coulter counter with multisizer iie coulter counter for particle size measurement.
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