|
Device | MEDTRONIC COREVALVE AND COREVALVE EVOLUT R SYSTEMS |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | Medtronic, Inc. 710 Medtronic Parkway Minneapolis,, MN 55432 |
PMA Number | P130021 |
Supplement Number | S016 |
Date Received | 07/08/2015 |
Decision Date | 11/10/2015 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01240902
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFYING THE LABELING TO REMOVE THE PRECAUTIONS REGARDING PATIENTS WITH LOW FLOW/LOW GRADIENT AND END-STAGE RENAL DISEASE. |
Post-Approval Study | Show Report Schedule and Study Progress |