PMA P100023S072

Device: ION PACILITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P100023
Supplement: S072
Product code: NIQ
Decision date: 2013-06-21
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL TO MANUFACTURE THE FLUSHING NEEDLE (ALSO KNOWN AS TIP BARRELL 30 GAUGE) ACCESSORY WITH AN ALTERNATIVE RESIN PROVIDED BY A NEW SUPPLIER.

Current openFDA PMA Record

Device: ION PACILITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P100023
Supplement: S072
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2013-06-21
Decision code: APPR
Date received: 2013-03-29
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO MANUFACTURE THE FLUSHING NEEDLE (ALSO KNOWN AS TIP BARRELL 30 GAUGE) ACCESSORY WITH AN ALTERNATIVE RESIN PROVIDED BY A NEW SUPPLIER.