PMA P910030S005

Device: GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG
Applicant: Cook, Inc.
PMA number: P910030
Supplement: S005
Product code: MAF
Decision date: 1997-05-12
Generic name: STENT, CORONARY
Approval order statement: APPROVAL FOR A MODIFIED VERSION OF THE ORIGINAL GIANTURCO-ROUBIN CORONARY FLEX STENT(TM). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GR II(TM) CORONARY STENT AND IS INDICATED FOR TREATMENT OF ACUTE OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN VESSELS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.1 MM TO 4.0 MM.

Current openFDA PMA Record

Device: GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG
Applicant: Cook, Inc.
PMA number: P910030
Supplement: S005
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 1997-05-12
Decision code: APPR
Date received: 1996-11-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MODIFIED VERSION OF THE ORIGINAL GIANTURCO-ROUBIN CORONARY FLEX STENT(TM). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GR II(TM) CORONARY STENT AND IS INDICATED FOR TREATMENT OF ACUTE OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN VESSELS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.1 MM TO 4.0 MM.