Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310
Classification Namereplacement heart-valve
Generic Namereplacement heart valve
Regulation Number870.3925
ApplicantMEDTRONIC HEART VALVES
PMA NumberP990064
Supplement NumberS014
Date Received02/06/2006
Decision Date06/05/2006
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to: 1) the jar retainer used for both the mitral and aortic configurations of the mosaic bioprostheses; 2) the serial number tag for mitral and aortic configurations of the mosaic bioprostheses; 3) the valve holder for the mosaic mitral bioprostheses, and 4) the "instructions for use": to accommodate the changes in the retainer, tag and mitral holder.
-
-