PMA P110004S001

Device: NIRXCELL COCR CORONARY STENT ON RX SYSTEM
Applicant: Medinol, Ltd.
PMA number: P110004
Supplement: S001
Product code: MAF
Decision date: 2013-12-19
Classification: Stent, Coronary
Generic name: STENT, CORONARY
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE STENT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NIRXCELL COCR CORONARY STENT ON RX SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE ASSOCIATED WITH STENOTIC LESIONS IN DE NOVO NATIVE CORONARY ARTERIES (LENGTH ¿30MM) WITH A REFERENCE VESSEL DIAMETER OF 2.50MM TO 4.00MM.

Current openFDA PMA Record#

Device: NIRXCELL COCR CORONARY STENT ON RX SYSTEM
Applicant: Medinol, Ltd.
PMA number: P110004
Supplement: S001
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2013-12-19
Decision code: APPR
Date received: 2013-02-22
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE STENT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NIRXCELL COCR CORONARY STENT ON RX SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE ASSOCIATED WITH STENOTIC LESIONS IN DE NOVO NATIVE CORONARY ARTERIES (LENGTH ¿30MM) WITH A REFERENCE VESSEL DIAMETER OF 2.50MM TO 4.00MM.