PMA P230007S007

Device
TriClip G4 System
Applicant
ABBOTT MEDICAL
PMA number
P230007
Supplement
S007
Product code
NPS
Decision date
2024-11-13
Classification
Cardiovascular
Generic name
Tricuspid valve repair device, percutaneously delivered
Approval order statement
approval of the revised protocol for the post-approval study (PAS) referenced above

Current openFDA PMA Record#

Device
TriClip G4 System
Applicant
ABBOTT MEDICAL
PMA number
P230007
Supplement
S007
Product code
NPS
Generic name
Tricuspid valve repair device, percutaneously delivered
Decision date
2024-11-13
Decision code
APPR
Date received
2024-10-15
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
approval of the revised protocol for the post-approval study (PAS) referenced above