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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 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.
 
DeviceCrown PRT Aortic Pericardial Heart Valve with PR Treatment
Generic Nameheart-valve, non-allograft tissue
ApplicantCorcym Canada Corp
5005 N. Fraser Way
Burnaby V5J 5M1
PMA NumberP060038
Supplement NumberS026
Date Received11/04/2015
Decision Date01/13/2016
Withdrawal Date10/17/2022
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL DL, NAMELY THE ADDITION OF RADIOGRAPHIC MARKERS ON THE SEWING RING AND ADDITION OF VISIBLE MARKERS ON THE SEWING CUFF. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CROWN PRT AORTIC PERICARDIAL HEART VALVE WITH PR TREATMENT AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
-
-