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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 NumberS002
Date Received11/02/1994
Decision Date03/01/1996
Product Code
MJS
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for release of the final product based on usp sterility testing performed by molecular biosystems, inc. Rather than namsa, irvine, ca.
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