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 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
| Device | ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES |
| Generic Name | Contrast Media, Ultrasound |
| Applicant | MOLECULAR BIOSYSTEMS, INC. |
| Date Received | 1994-09-12 |
| Decision Date | 1995-07-31 |
| PMA | P900059 |
| Supplement | S001 |
| Product Code | MJS |
| Advisory Committee | Radiology |
| Supplement Type | Special (immediate 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) |