PMA P900059S002

Device: ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
Applicant: Molecular Biosystems, Inc.
PMA number: P900059
Supplement: S002
Product code: MJS
Decision date: 1996-03-01
Generic name: Contrast media, ultrasound
Approval order statement: APPROVAL FOR RELEASE OF THE FINAL PRODUCT BASED ON USP STERILITY TESTING PERFORMED BY MOLECULAR BIOSYSTEMS, INC. RATHER THAN NAMSA, IRVINE, CA

Current openFDA PMA Record#

Device: ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
Applicant: Molecular Biosystems, Inc.
PMA number: P900059
Supplement: S002
Product code: MJS
Generic name: Contrast media, ultrasound
Decision date: 1996-03-01
Decision code: APPR
Date received: 1994-11-02
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR RELEASE OF THE FINAL PRODUCT BASED ON USP STERILITY TESTING PERFORMED BY MOLECULAR BIOSYSTEMS, INC. RATHER THAN NAMSA, IRVINE, CA