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 | ON-X PROSTHETIC HEART VALVE |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | On-X Life Technologies, Inc. 1655 ROBERTS BLVD NW KENNESAW, GA 30144 |
PMA Number | P000037 |
Supplement Number | S030 |
Date Received | 10/23/2012 |
Decision Date | 04/01/2015 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00291525
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Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING CHANGE TO ALLOW AORTIC VALVE REPLACEMENT PATIENTS TO BE TREATED USING A LOWERED ANTICOAGULATION TARGET. |
Post-Approval Study | Show Report Schedule and Study Progress |
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