Atlas FDA

MitraClip G5 System

FDA premarket approval P100009/S067 · decided 2024-12-31

Approval details

PMA number
P100009
Supplement
S067
Supplement type
Normal 180 Day Track
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
MitraClip G5 System
Generic name
Mitral valve repair devices
Applicant
ABBOTT MEDICAL
Date received
2024-07-03
Decision date
2024-12-31
Days to decision
181 days
Decision code
APPR
Product code
NKM
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

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EnSite™ X EP System (K262006)Abbott Medical2026-07-15
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