Atlas FDA

TriClip G5 Delivery System

FDA premarket approval P230007/S005 · decided 2024-12-31

Approval details

PMA number
P230007
Supplement
S005
Supplement type
Normal 180 Day Track
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
TriClip G5 Delivery System
Generic name
Tricuspid valve repair device, percutaneously delivered
Applicant
ABBOTT MEDICAL
Date received
2024-07-03
Decision date
2024-12-31
Days to decision
181 days
Decision code
APPR
Product code
NPS
Advisory committee
Cardiovascular
Expedited review
No
Location
St. Paul, MN
Statement
Approval for the MitraClip G5 Delivery System and the TriClip G5 Delivery System, which include modifications to the Delivery System Handles and simplification of the IFU procedural steps to improve the ergonomics of the Clip Delivery System to enhance physician usability, as well as minor labeling, packaging, specification, and manufacturing process changes. Two of the changes, a minor specification change and an alternate Female Luer component, will also apply to the MitraClip G4 Delivery Syst

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510(k) clearances by this applicant

RecordFirmDate
EnSite™ X EP System (K262006)Abbott Medical2026-07-15
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OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (K253459)ABBOTT MEDICAL2026-04-24
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Armada™ 14 NC PTA Catheter (K252512)ABBOTT MEDICAL2026-02-13
Assert-IQ (DM5100) (K253516)ABBOTT MEDICAL2025-12-18