Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: HANCOCK II PORCINE BIOPROSTHESIS
• Generic Name: replacement Heart-valve
• Regulation Number: 870.3925
• Applicant: Medtronic, Inc.; 1851 EAST DEERE AVE.; SANTA ANA, CA 92705
• PMA Number: P980043
• Date Received: 10/29/1998
• Decision Date: 09/28/1999
• Product Code: DYE
• Docket Number: 99M-4279
• Notice Date: 10/15/1999
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
Approval for the Medtronic Hancock(R) II Bioprosthetic Heart Valve, Models T505 (odd sizes 21 through 29 mm) and T510 (odd sizes 25 through 33 mm). This device is indicated for the replacement of pathologic or prosthetic aortic and mitral valves.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002 S004 S005 S007 S008 S009 S010 S012 S013 S014 ; S015 S016 S017 S018 S020 S021 S022 S023 S024 S025 S026 S027 ; S028 S029 S030 S032 S033 S034 S035 S036 S037 S038 S039 S040 ; S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 ; S053 S054 S055 S056 S057 S058 S059 S061 S062 S063 S065 S066 ; S067 S068 S069 S070 S071 S072 S073 S074 S075 S076 S077 S078