FDA.reportPublic FDA data

PMA P230007S012

Device
TriClip G4 Delivery System;TriClip G5 Delivery System
Applicant
ABBOTT MEDICAL
PMA number
P230007
Supplement
S012
Product code
NPS
Decision date
2025-05-18
Classification
Cardiovascular
Generic name
Tricuspid valve repair device, percutaneously delivered
Approval order statement
a change in the incoming inspection requirement for functional inspection points for a subassembly component used in the manufacture of the MitraClip and TriClip clip delivery systems (CDS)

Current openFDA PMA Record#

Device
TriClip G4 Delivery System;TriClip G5 Delivery System
Applicant
ABBOTT MEDICAL
PMA number
P230007
Supplement
S012
Product code
NPS
Generic name
Tricuspid valve repair device, percutaneously delivered
Decision date
2025-05-18
Decision code
OK30
Date received
2025-04-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a change in the incoming inspection requirement for functional inspection points for a subassembly component used in the manufacture of the MitraClip and TriClip clip delivery systems (CDS)