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 AND OMNICARBON CARDIAC VALVES |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | MEDICALCV, INC. 9725 SOUTH ROBERT TRAIL INVER GROVE HEIGHTS, MN 55077 |
PMA Number | P830039 |
Supplement Number | S008 |
Date Received | 07/22/1998 |
Decision Date | 09/25/1998 |
Withdrawal Date
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09/17/2007 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications to various cleaning methods utilized during production of the Omniscience(R) valve to remove chlorofluorocarbon solvents. |
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