|
Device | MITRACLIP CLIP DELIVERY SYSTEM |
Generic Name | Mitral valve repair devices |
Applicant | Abbott Medical 177 Country Road B East St. Paul, MN 55117 |
PMA Number | P100009 |
Supplement Number | S005 |
Date Received | 05/01/2014 |
Decision Date | 05/22/2014 |
Product Code |
NKM |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00209274
|
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 A LABELING CHANGE THAT INCLUDED ADDITIONS TO THE LIST OF ANTICIPATED EVENTS AND CONVERTING CERTAIN PROCEDURAL CAUTION STATEMENTS TO WARNING STATEMENTS. |
Post-Approval Study | Show Report Schedule and Study Progress |