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 | OMNISCEINCE PROSTHETIC CARDIAC VALVE |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | MEDICALCV, INC. 9725 SOUTH ROBERT TRAIL INVER GROVE HEIGHTS, MN 55077 |
PMA Number | P830039 |
Supplement Number | S002 |
Date Received | 01/25/1988 |
Decision Date | 08/18/1988 |
Withdrawal Date
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09/17/2007 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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