PMA P060008S049

Device: TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS
Applicant: Boston Scientific Corp
PMA number: P060008
Supplement: S049
Product code: NIQ
Decision date: 2010-05-13
Generic name: Coronary drug-eluting stent
Approval order statement: REPLACEMENT OF THE FINAL INSPECTION CAMERA WITH ONE THAT PERFORMS THE EXISTING CATHETER FINAL INSPECTION PROCESS AT THE SDS FINAL INSPECTION STATION.

Current openFDA PMA Record

Device: TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS
Applicant: Boston Scientific Corp
PMA number: P060008
Supplement: S049
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2010-05-13
Decision code: OK30
Date received: 2010-04-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REPLACEMENT OF THE FINAL INSPECTION CAMERA WITH ONE THAT PERFORMS THE EXISTING CATHETER FINAL INSPECTION PROCESS AT THE SDS FINAL INSPECTION STATION.