|
Device | MitraClip NT, NTR, and XTR 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 | S032 |
Date Received | 06/24/2019 |
Decision Date | 07/18/2019 |
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 Use of an additional alternative Bacterial Endotoxin testing laboratory for the MitraClip NTR/XTR and G4 devices. |