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 | HANCOCK MODIFIED ORIFICE II AORTIC BIOPROSTHESIS |
Generic Name | heart-valve, non-allograft tissue |
Applicant | MEDTRONIC HEART VALVES 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P790007 |
Supplement Number | S013 |
Date Received | 05/13/1996 |
Decision Date | 12/10/1996 |
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 TWO ADD'L STYLES (TYPE F AND TYPE G) OF THE MODEL 250 VALVE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES HANCOCK(R) MODIFIED ORIFICE II AORTIC BIOPROSTHESIS, MODEL 250, EXTENDED SUPRA-ANNULAR FLANGE (TYPE F) AND HANCOCK(R) MODIFIED ORIFICE II AORTIC BIOPROSTHESIS, MODEL 250, SUPRA-ANNULAR FLANGE (TYPE G). THE INDICATION FOR USE AND AVAILABLE SIZES (19, 21, 23, AND 25 MM) FOR THE MDOEL 250 VALVES HAVE NOT CHANGED. |
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