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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) ALBUMIN (HUMAN) 5%, SONICATED
Generic NameContrast media, ultrasound
ApplicantMolecular Biosystems, Inc.
10030 Barnes Canyon Rd.
San Diego, CA 92121
PMA NumberP900059
Supplement NumberS004
Date Received09/03/1996
Decision Date06/17/1997
Product Code MJS 
Docket Number 97M-0392
Notice Date 09/23/1997
Advisory Committee Radiology
Supplement TypePanel 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 ALBUNEX(R). THE DEVICE IS INDICATED FOR USE WITH TRANSVAGINAL ULTRASOUND TO ASSESS FALLOPIAN TUBE PATENCY.
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