PMA P100023S080

Device: ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P100023
Supplement: S080
Product code: NIQ
Decision date: 2014-05-19
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL TO REDUCE THE KINETIC DRUG RELEASE (KDR) SAMPLE QUANTITY FOR BATCH RELEASE AND STABILITY TESTING.

Current openFDA PMA Record

Device: ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P100023
Supplement: S080
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2014-05-19
Decision code: APPR
Date received: 2013-11-25
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO REDUCE THE KINETIC DRUG RELEASE (KDR) SAMPLE QUANTITY FOR BATCH RELEASE AND STABILITY TESTING.