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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED
Classification Namecontrast media, ultrasound
Generic Namealbumin ultrasound contrast microspheres
ApplicantMALLINCKRODT MEDICAL
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
Expedited Review Granted? No
Combination Product No
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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