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 an extension of shelf life from three years to ten years after the initial sterilization of the omniscience valve.
| Device | OMNISCEINCE CARDIAC VALVE PROSTHESIS EXTENSION OF SHELF LIFE |
| Generic Name | Heart-valve, Mechanical |
| Applicant | MEDICALCV, INC. |
| Date Received | 1996-09-30 |
| Decision Date | 1997-03-26 |
| PMA | P830039 |
| Supplement | S006 |
| 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 |