- Device
- ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
- Applicant
- Molecular Biosystems, Inc.
- PMA number
- P900059
- Supplement
- S001
- Product code
- MJS
- Generic name
- Contrast media, ultrasound
- Decision date
- 1995-07-31
- Decision code
- APPR
- Date received
- 1994-09-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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