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 has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameBILEAFLET-CENTER OPENING CARDIAC VALVE
Classification Nameheart-valve, mechanical
Generic Nameheart valve, bileaflet
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Date Received01/22/1981
Decision Date12/17/1982
Product Code
LWQ[ Registered Establishments with LWQ ]
Docket Number 83M-0004
Notice Date 03/01/1983
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S006 S008 
S009 S010 S011 S012 S013 S014 
S015 S016 S017 S018 S019 S020 
S021 S022 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 S060 S061 S062 S063 S064 
S065 S066 S067 S068 S069 S070 
S071 S072 S073 S074 S076 S077 
S078 S079 S080 S081 S082 S083 
-
-