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 release of final product based on results from kinetic quantitative chromogenic lal baterial endotoxin test and replacement of taii coulter counter with multisizer iie coulter counter for particle size measurement
| Device | ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES |
| Generic Name | Contrast Media, Ultrasound |
| Applicant | MOLECULAR BIOSYSTEMS, INC. |
| Date Received | 1995-06-05 |
| Decision Date | 1995-08-28 |
| PMA | P900059 |
| Supplement | S003 |
| Product Code | MJS |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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) |