PMA P110035S019

Device: EPIC VASCULAR SELF EXPANDING STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P110035
Supplement: S019
Product code: NIO
Decision date: 2013-09-27
Classification: Stent, Iliac
Generic name: STENT, ILIAC
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: EPIC VASCULAR SELF EXPANDING STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P110035
Supplement: S019
Product code: NIO
Generic name: STENT, ILIAC
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.