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.
 
DeviceCARDIOGENESIS TMR SYSTEM
Generic NameSYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
ApplicantCRYOLIFE, INC.
1655 ROBERTS BLVD., N.W.
KENNESAW, GA 30144
PMA NumberP970029
Supplement NumberS026
Date Received04/09/2014
Decision Date05/07/2014
Product Code MNO 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR INCLUDING THE POST APPROVAL STUDY LABELING CHANGES OF THE PEARL 8.0 DEVICE INTO THE INSTRUCTIONS FOR USE OF THE PEARL 5.0 AND THE SOLOGRIP III HANDPIECES AS WELL AS ADDING SOME CLARIFYING STATEMENTS TO ENSURE THE SAFE HANDLING OF THE HANDPIECES.
-
-