|
Device | MEDTRONIC COREVALUE TM SYSTEM, |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | Medtronic, Inc. 710 Medtronic Parkway Minneapolis,, MN 55432 |
PMA Number | P130021 |
Supplement Number | S003 |
Date Received | 03/27/2014 |
Decision Date | 04/03/2014 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE LABELING TO CLARIFY THE INDICATIONS FOR USE AND THE INSTRUCTIONS FOR POST-IMPLANTATION DILATATION. |