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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 NumberS001
Date Received09/12/1994
Decision Date07/31/1995
Product Code MJS 
Advisory Committee Radiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR 2 TRAINING VIDOES.FDA HAS RECEIVED A JOURNAL ADVERTISING INSERT, PRODUCT FOLDER, & 2 JOURNAL ARTICLES & FIND THAT THEY ARE CONSISTENT WITH APPROVED LABELING.EXPIRATION DATING 12 MONTHS REFRIGERATED AT 2 TO 8 DEGREES CELSIUS
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