| 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 | ATS 3F AORTIC BIOPROSTHESIS |
|---|
| Generic Name | heart-valve, non-allograft tissue |
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| Applicant | MEDTRONIC Inc.
710 MEDTRONIC PARKWAY NE
MINNEAPOLIS, MN 55432 |
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| PMA Number | P060025 |
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| Date Received | 09/27/2006 |
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| Decision Date | 10/30/2008 |
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|
Withdrawal Date
|
10/26/2016 |
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| Product Code |
LWR |
| Docket Number | 08M-0594 |
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| Notice Date | 11/14/2008 |
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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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Approval Order Statement
APPROVAL FOR THE ATS 3F AORTIC BIOPROSTHESIS, MODEL 1000 (SIZES 21, 23, 25, 27 AND 29 MM). THE DEVICE IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S013 S003 S004 S005 S006 S008 S014 S009 S012 S010 S011
S007 S001 S002 |
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