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 cardiac valve prosthesis in the additional size of 21 mm of the model 3313 (aortic) and size 25 mm of the model 3523 (mitral). The supplement requested approval of these sizes as an addition to the existing, approved (july 26, 2001; p830039/s007) product line of aortic sizes 23, 25, 27 and 29 mm, and mitral sizes 27, 29, 31, and 33 mm. The device is indicated for the replacement of malfunctioning native or prosthetic aortic and mitral valves.
| Device | OMNICARBON CARDIAC VALVE PROSTHESIS |
| Generic Name | Heart-valve, Mechanical |
| Applicant | MEDICALCV, INC. |
| Date Received | 2002-05-07 |
| Decision Date | 2002-10-29 |
| PMA | P830039 |
| Supplement | S011 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day 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 |
| 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 |