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 modifications to the omni-series instructions for handling and use.
| Device | OMNISCIENCE CARDIAC VALVE |
| Generic Name | Heart-valve, Mechanical |
| Applicant | MEDICALCV, INC. |
| Date Received | 1999-05-04 |
| Decision Date | 1999-10-29 |
| PMA | P830039 |
| Supplement | S010 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDICALCV, INC. 9725 South Robert Trail inver Grove Heights, MN 55077 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P830039 | Original Filing | |
| S011 | 2002-05-07 | Normal 180 Day Track |
| S010 | 1999-05-04 | Normal 180 Day Track |
| S009 | 1998-12-08 | 30-day Notice |
| S008 | 1998-07-22 | Real-time Process |
| S007 | 1996-10-24 | Panel Track |
| S006 | 1996-09-30 | Normal 180 Day Track |
| S005 | ||
| S004 | ||
| S003 | ||
| S002 | 1988-01-25 | Normal 180 Day Track |
| S001 |