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 II PORCINE BIOPROSTHESIS MODEL T505 (AORTIC) |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P980043 |
Supplement Number | S002 |
Date Received | 05/01/2002 |
Decision Date | 10/28/2002 |
Product Code |
DYE |
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 MODIFICATIONS TO THE VALVE HOLDERS FOR THE HANCOCK II BIOPROSTHESIS. THE HOLDERS ARE TO BE USED WITH THE FOLLOWING APPROVED VALVE MODELS AND SIZES: HANCOCK II PORCINE BIOPROSTHESIS, MODEL T505 (AORTIC, SIZES 21, 23, 25, 27, AND 29 MM. THESE AORTIC VALVES ARE INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES. |
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