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 | S001 |
Date Received | 09/07/2001 |
Decision Date | 03/06/2002 |
Product Code |
LWQ |
Docket Number | 02M-0255 |
Notice Date | 06/05/2002 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ON-X PROSTHETIC HEART VALVE, MODEL ONXM IN SIZES 25 MM, 27/29 MM, 31/33 MM, AND MODEL ONXMC IN SIZE 25/33 MM IN THE MITRAL POSITION. THIS DEVICE IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC HEART VALVES IN THE MITRAL POSITION. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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