PMA P970035S008

Device: GFX-XP/GFX2 CORONARY STENT SYSTEM
Applicant: Medtronic, Ireland
PMA number: P970035
Supplement: S008
Product code: MAF
Decision date: 1999-04-08
Generic name: STENT, CORONARY
Approval order statement: Approval for the Medtronic AVE GFX(R) 2 Over-The-Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length < 30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 mm to 4.0 mm. Long term outcome (beyond six months) for this permanent implant is unknown at present.

Current openFDA PMA Record

Device: GFX-XP/GFX2 CORONARY STENT SYSTEM
Applicant: Medtronic, Ireland
PMA number: P970035
Supplement: S008
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 1999-04-08
Decision code: APPR
Date received: 1998-10-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Medtronic AVE GFX(R) 2 Over-The-Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length < 30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 mm to 4.0 mm. Long term outcome (beyond six months) for this permanent implant is unknown at present.