Premarket Approval (PMA)

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: MOSAIC PORCINE BIOPROSTHESIS MODELS 305, 310
• Generic Name: replacement Heart-valve
• Regulation Number: 870.3925
• Applicant: Medtronic, Inc.; 1851 EAST DEERE AVE.; SANTA ANA, CA 92705
• PMA Number: P990064
• Supplement Number: S009
• Date Received: 12/22/2003
• Decision Date: 01/23/2004
• Product Code: DYE
• Advisory Committee: Cardiovascular
• Supplement Type: Special (Immediate Track)
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE INSTRUCTIONS FOR USE.