|
Device | OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | MEDTRONIC ATS MEDICAL, INC. 3800 ANNAPOLIS LANE, SUITE 175 PLYMOUTH, MN 55447 |
PMA Number | P990046 |
Supplement Number | S034 |
Date Received | 07/01/2013 |
Decision Date | 07/30/2013 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR REVISING THE LIST OF POTENTIAL ADVERSE EVENTS IN THE INSTRUCTIONS FOR USE. |
Post-Approval Study | Show Report Schedule and Study Progress |