PMA P100023S111

Device: ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P100023
Supplement: S111
Product code: NIQ
Decision date: 2014-12-18
Generic name: Coronary drug-eluting stent
Approval order statement: ADD ADDITIONAL LINES FOR THE MANUFACTURE OF THE STENT DELIVERY CATHETER OUTER COMPONENT AT THE GALWAY IRELAND MANUFACTURING FACILITY.

Current openFDA PMA Record

Device: ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P100023
Supplement: S111
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2014-12-18
Decision code: OK30
Date received: 2014-11-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADD ADDITIONAL LINES FOR THE MANUFACTURE OF THE STENT DELIVERY CATHETER OUTER COMPONENT AT THE GALWAY IRELAND MANUFACTURING FACILITY.