PMA P900059S003

Device: ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
Applicant: Molecular Biosystems, Inc.
PMA number: P900059
Supplement: S003
Product code: MJS
Decision date: 1995-08-28
Generic name: Contrast media, ultrasound
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

Current openFDA PMA Record#

Device: ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
Applicant: Molecular Biosystems, Inc.
PMA number: P900059
Supplement: S003
Product code: MJS
Generic name: Contrast media, ultrasound
Decision date: 1995-08-28
Decision code: APPR
Date received: 1995-06-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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