PMA P100009S042

Device
MitraClip NTR/XTR Delivery System
Applicant
ABBOTT MEDICAL
PMA number
P100009
Supplement
S042
Product code
NKM
Decision date
2021-06-03
Generic name
Mitral valve repair devices
Approval order statement
Approval of nitinol gripper line change.

Current openFDA PMA Record#

Device
MitraClip NTR/XTR Delivery System
Applicant
ABBOTT MEDICAL
PMA number
P100009
Supplement
S042
Product code
NKM
Generic name
Mitral valve repair devices
Decision date
2021-06-03
Decision code
APPR
Date received
2021-03-31
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval of nitinol gripper line change.