PMA P230007S004

Device
TriClip G4 System
Applicant
ABBOTT MEDICAL
PMA number
P230007
Supplement
S004
Product code
NPS
Decision date
2024-05-31
Classification
Cardiovascular
Generic name
Tricuspid valve repair device, percutaneously delivered
Approval order statement
approval of the protocol for the Continued f/u of the Premarket Cohort post-approval study (PAS)

Current openFDA PMA Record#

Device
TriClip G4 System
Applicant
ABBOTT MEDICAL
PMA number
P230007
Supplement
S004
Product code
NPS
Generic name
Tricuspid valve repair device, percutaneously delivered
Decision date
2024-05-31
Decision code
APPR
Date received
2024-05-01
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
approval of the protocol for the Continued f/u of the Premarket Cohort post-approval study (PAS)