PMA P060008S106

Device: TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P060008
Supplement: S106
Product code: NIQ
Decision date: 2013-09-27
Generic name: Coronary drug-eluting stent
Approval order statement: P050019/S0179/27/13 CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311 USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.

Current openFDA PMA Record

Device: TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P060008
Supplement: S106
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2013-09-27
Decision code: OK30
Date received: 2013-08-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: P050019/S0179/27/13 CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311 USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.