This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for albunex(r). The device is indicated for use with transvaginal ultrasound to assess fallopian tube patency.
| Device | ALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED |
| Generic Name | Contrast Media, Ultrasound |
| Applicant | MOLECULAR BIOSYSTEMS, INC. |
| Date Received | 1996-09-03 |
| Decision Date | 1997-06-17 |
| Notice Date | 1997-09-23 |
| PMA | P900059 |
| Supplement | S004 |
| Product Code | MJS |
| Docket Number | 97M-0392 |
| Advisory Committee | Radiology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MOLECULAR BIOSYSTEMS, INC. 10030 Barnes Canyon Rd. san Diego, CA 92121 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900059 | Original Filing | |
| S004 | 1996-09-03 | Panel Track |
| S003 | 1995-06-05 | Normal 180 Day Track |
| S002 | 1994-11-02 | Normal 180 Day Track |
| S001 | 1994-09-12 | Special (immediate Track) |