| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA |
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| Generic Name | HEART-VALVE, MECHANICAL |
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| Applicant | On-X Life Technologies, Inc.
1655 Roberts Blvd., NW
Kennesaw, GA 30144 |
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| PMA Number | P000037 |
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| Date Received | 09/01/2000 |
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| Decision Date | 05/30/2001 |
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| Product Code |
LWQ |
| Docket Number | 01M-0270 |
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| Notice Date | 06/19/2001 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE ON-X. PROSTHETIC HEART VALVE, MODEL ONXA IN THE AORTIC POSITION INCLUDING SIZES 19, 21, 23, 25, AND 27/29 MM. THIS DEVICE IS INDICATED FOR REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC HEART VALVES IN THE AORTIC POSITION. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023
S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S035 S036
S037 S038 S039 S040 S041 S043 S044 S045 S046 S047 S048 S050
S051 S052 S053 S054 S056 S057 S059 S060 S061 S062 S063 S064
S065 S066 S067 S068 |
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