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 the omnicarbon(tm) cardiac valve prosthesis, aortic model 3313 in sizes 23, 25, 27, and 29 mm, and mitral supra-annular model 3523 in sies 27, 29, 31, and 33 mm. The device is indicated for the replacement of dysfunctioning native or prosthetic aortic or mitral heart valves.
| Device | OMNICARBON CARDIAC VALVE PROSTHESIS |
| Generic Name | Heart-valve, Mechanical |
| Applicant | MEDICALCV, INC. |
| Date Received | 1996-10-24 |
| Decision Date | 2001-07-26 |
| Notice Date | 2001-09-05 |
| PMA | P830039 |
| Supplement | S007 |
| Product Code | LWQ |
| Docket Number | 01M-0380 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDICALCV, INC. 9725 South Robert Trail inver Grove Heights, MN 55077 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |