Note: 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. |
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Device | OMNISCIENCE CARDIAC VALVE PROSTHESIS |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | MEDICALCV, INC. 9725 SOUTH ROBERT TRAIL INVER GROVE HEIGHTS, MN 55077 |
PMA Number | P830039 |
Supplement Number | S009 |
Date Received | 12/08/1998 |
Decision Date | 12/30/1998 |
Withdrawal Date
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09/17/2007 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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 |
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