PMA P230007S021

Device
TriClip Systems
Applicant
ABBOTT MEDICAL
PMA number
P230007
Supplement
S021
Product code
NPS
Decision date
2026-05-14
Classification
Cardiovascular
Generic name
Tricuspid valve repair device, percutaneously delivered
Approval order statement
a supplier manufacturing change for the independent gripper line components of the MitraClip and TriClip Delivery Systems

Current openFDA PMA Record#

Device
TriClip Systems
Applicant
ABBOTT MEDICAL
PMA number
P230007
Supplement
S021
Product code
NPS
Generic name
Tricuspid valve repair device, percutaneously delivered
Decision date
2026-05-14
Decision code
OK30
Date received
2026-04-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a supplier manufacturing change for the independent gripper line components of the MitraClip and TriClip Delivery Systems