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.
1. Mixture of sterilant gas for the ethylene oxide gas now used 2. A change in the vehicle for the bacillus subtilis var. Niger biological indicator samples used for sterility 3. Reduction of the incubation time of the biological indicators
| Device | OMNISCIENCE CARDIAC VALVE PROSTHESIS |
| Generic Name | Heart-valve, Mechanical |
| Applicant | MEDICALCV, INC. |
| Date Received | 1998-12-08 |
| Decision Date | 1998-12-30 |
| PMA | P830039 |
| Supplement | S009 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |