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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
Generic NameContrast media, ultrasound
ApplicantMolecular Biosystems, Inc.
10030 Barnes Canyon Rd.
San Diego, CA 92121
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/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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