• 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.
 
DeviceOPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
MEDTRONIC ATS MEDICAL, INC.
3800 annapolis lane, suite 175
plymouth, MN 55447
PMA NumberP990046
Supplement NumberS035
Date Received07/08/2013
Decision Date08/07/2013
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
REVIEW OF: 1) INSTALLATION QUALIFICATION (IQ) REPORTS FOR 4 PIECES OF EQUIPMENTRELATED TO AN ALREADY APPROVED SITE CHANGE SUPPLEMENT; AND 2) ONE PROCESS QUALIFICATION (PQ) REPORT FOR ONE PIECE OF EQUIPMENT RELATED TO AN ALREADY APPROVED SITE CHANGE SUPPLEMENT. THESE CHANGES APPLY TO THE OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT.
-
-