Atlas FDA

GFX SL OVER-THE-WIRE CORONARY STENT SYSTEM

FDA premarket approval P970035/S011 · decided 1999-06-03

Approval details

PMA number
P970035
Supplement
S011
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
GFX SL OVER-THE-WIRE CORONARY STENT SYSTEM
Generic name
STENT, CORONARY
Applicant
Medtronic, Ireland
Date received
1998-11-12
Decision date
1999-06-03
Days to decision
203 days
Decision code
APPR
Product code
MAF
Advisory committee
Cardiovascular
Expedited review
No
Location
Galway
Statement
Approval for the Medtronic AVE S540(TM) Over-The_Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in the treatment of acute or threatened closure during a planned interventional procedure in de novo lesions (length <24 mm) within a native coronary artery or arterial bypass graft conduit with a reference diameter between 2.2 and 2.9mm. Long term outcome (beyond 30 days) for this permanent implant is unknown at present.

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