PMA P230007S010

Device
TriClip G4 System
Applicant
ABBOTT MEDICAL
PMA number
P230007
Supplement
S010
Product code
NPS
Decision date
2025-05-09
Classification
Cardiovascular
Generic name
Tricuspid valve repair device, percutaneously delivered
Approval order statement
Approval for minor design, material, and manufacturing changes to the Lock Knob Shaft component of the delivery system.

Current openFDA PMA Record#

Device
TriClip G4 System
Applicant
ABBOTT MEDICAL
PMA number
P230007
Supplement
S010
Product code
NPS
Generic name
Tricuspid valve repair device, percutaneously delivered
Decision date
2025-05-09
Decision code
APPR
Date received
2025-02-14
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for minor design, material, and manufacturing changes to the Lock Knob Shaft component of the delivery system.