|
Device | Medtronic CoreValve System |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | Medtronic, Inc. 710 Medtronic Parkway Minneapolis,, MN 55432 |
PMA Number | P130021 |
Supplement Number | S034 |
Date Received | 03/09/2017 |
Decision Date | 05/09/2017 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the protocol for the post-approval study (PAS) protocol. |