|
Device | MITRACLIP NT 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 | S019 |
Date Received | 05/26/2016 |
Decision Date | 06/24/2016 |
Product Code |
NKM |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Add the option to sterilize the MitraClip NT Clip Delivery System (CDS) and Steerable Guide Catheter (SGC) at the existing alternate sterilization site. |