PMA P020036S031

Device: SMART AND SMART CONTROL NITINOL STENT SYSTEM
Applicant: Cordis US Corporation
PMA number: P020036
Supplement: S031
Product code: NIO
Decision date: 2015-07-31
Classification: Stent, Iliac
Generic name: STENT, ILIAC
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 NITINOL STENT SYSTEM
Applicant: Cordis US Corporation
PMA number: P020036
Supplement: S031
Product code: NIO
Generic name: STENT, ILIAC
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.