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. |
|
Device | HANCOCK II BIOPROSTHESIS |
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 | S021 |
Date Received | 07/31/2009 |
Decision Date | 09/29/2009 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A DESIGN MODIFICATION TO THE DISPOSABLE CINCH AORTIC VALVE HOLDER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CINCH II VALVE HOLDER AND IS INDICATED FOR THE TEMPORARY DEFLECTION OF THE VALVE STENT POSTS TO PROVIDE SURGICAL EASE OF IMPLANTATION OF THE BIOPROSTHESIS. |
|
|