PMA P900059
- Device
- ALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED
- Applicant
- Molecular Biosystems, Inc.
- PMA number
- P900059
- Supplement
- S004
- Product code
- MJS
- Decision date
- 1997-06-17
- Generic name
- Contrast media, ultrasound
- Approval order statement
- APPROVAL FOR ALBUNEX(R). THE DEVICE IS INDICATED FOR USE WITH TRANSVAGINAL ULTRASOUND TO ASSESS FALLOPIAN TUBE PATENCY.
Current openFDA PMA Record#
- Device
- ALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED
- Applicant
- Molecular Biosystems, Inc.
- PMA number
- P900059
- Supplement
- S004
- Product code
- MJS
- Generic name
- Contrast media, ultrasound
- Decision date
- 1997-06-17
- Decision code
- APPR
- Date received
- 1996-09-03
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ALBUNEX(R). THE DEVICE IS INDICATED FOR USE WITH TRANSVAGINAL ULTRASOUND TO ASSESS FALLOPIAN TUBE PATENCY.