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 NameCARBOMEDICS PROSTHETIC HEART VALVE
Classification Nameheart-valve, mechanical
Generic Namecarbomedics prosthetic heart valve
ApplicantSULZER CARBOMEDICS, INC.
PMA NumberP900060
Supplement NumberS022
Date Received01/22/2001
Decision Date02/16/2001
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Increasing the sterilization load size for cphv(tm) and utilize mixed loads of cphv(tm) and annuloplasty rings (annuloflo(r), and/or annuloflex(tm), to maximum of 384 barriers in the same cycle at th eaustin and calgary facilities.
-
-