PMA P230007S002

Device
TriClip G4 Delivery System
Applicant
ABBOTT MEDICAL
PMA number
P230007
Supplement
S002
Product code
NPS
Decision date
2024-06-20
Classification
Cardiovascular
Generic name
Tricuspid valve repair device, percutaneously delivered
Approval order statement
alternate model numbers under the existing trade name for the MitraClip G4 System, and alternate trade name and model numbers for the TriClip G4 System

Current openFDA PMA Record#

Device
TriClip G4 Delivery System
Applicant
ABBOTT MEDICAL
PMA number
P230007
Supplement
S002
Product code
NPS
Generic name
Tricuspid valve repair device, percutaneously delivered
Decision date
2024-06-20
Decision code
APPR
Date received
2024-04-22
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
alternate model numbers under the existing trade name for the MitraClip G4 System, and alternate trade name and model numbers for the TriClip G4 System