PMA P120002S006

Device: SMART AND SMART CONTROL VASCULAR STENT SYSTEM
Applicant: Cordis US Corporation
PMA number: P120002
Supplement: S006
Product code: NIP
Decision date: 2015-07-31
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT NDC, COSTA RICA, S.R.L., EL COYOL ALAJUELA, COSTA RICA, A CONTRACT MANUFACTURER FOR CORDISSMART AND SMART CONTROL NITINOL STENT SYSTEMS.

Current openFDA PMA Record#

Device: SMART AND SMART CONTROL VASCULAR STENT SYSTEM
Applicant: Cordis US Corporation
PMA number: P120002
Supplement: S006
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2015-07-31
Decision code: APPR
Date received: 2014-12-19
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT NDC, COSTA RICA, S.R.L., EL COYOL ALAJUELA, COSTA RICA, A CONTRACT MANUFACTURER FOR CORDISSMART AND SMART CONTROL NITINOL STENT SYSTEMS.