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 | FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P970031 |
Supplement Number | S013 |
Date Received | 07/28/2003 |
Decision Date | 12/08/2003 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM. THE SUPPLEMENT REQUESTED APPROVAL OF THIS SIZE AS AN ADDITION TO THE EXISTING, APPROVED (OCTOBER 31, 2001, UNDER SUPPLEMENT S010) PRODUCT LINE OF SIZES 19, 21, 23, 25, AND 27 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES. |
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