PMA P960010

Device: MEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM
Applicant: Medtronics Interventional Vascular
PMA number: P960010
Supplement: S001
Product code: MAF
Decision date: 1998-05-21
Generic name: STENT, CORONARY
Approval order statement: Approval for the Medtronic Model 6322 Wiktor(R) Rival(TM) Coronary Stent System. This device is indicated for the treatment of abrupt or threatened closure in patients with failed interventional therapy in native coronary arteries and bypass grafts vessels with reference diameters in the range of 3.0 to 4.5mm.

Current openFDA PMA Record#

Device: MEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM
Applicant: Medtronics Interventional Vascular
PMA number: P960010
Supplement: S001
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 1998-05-21
Decision code: APPR
Date received: 1997-11-25
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Medtronic Model 6322 Wiktor(R) Rival(TM) Coronary Stent System. This device is indicated for the treatment of abrupt or threatened closure in patients with failed interventional therapy in native coronary arteries and bypass grafts vessels with reference diameters in the range of 3.0 to 4.5mm.