|
Device | MITRACLIP CLIP DELIVERY SYSTEM AND MITRACLIP STEERABLE GUIDE CATHETER |
Generic Name | Mitral valve repair devices |
Applicant | Abbott Medical 177 Country Road B East St. Paul, MN 55117 |
PMA Number | P100009 |
Supplement Number | S010 |
Date Received | 03/30/2015 |
Decision Date | 11/18/2015 |
Product Code |
NKM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS US, LLC, IN LOS ANGELES, CALIFORNIA. |