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 | MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P970031 |
Supplement Number | S011 |
Date Received | 06/01/2001 |
Decision Date | 11/16/2001 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
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 THE FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODEL 995, SIZE 29 MM; IMPLANTATION TECHNIQUES, SUBCORONARY, FULL-ROOT, AND ROOT INCLUSION. THE SUPPLEMENT REQUESTED APPROVAL OF THIS SIZE AS AN ADDITION TO THE EXISTING, APPROVED PRODUCT LINE OF SIZES 19, 21, 23, 25, AND 27 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHESTIC AORTIC VALVES WITH THE OPTION OF AORTIC ROOT REPLACEMENT. |
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