PMA P010012S391

Device: EASYTRAK 2 CORONARY SINUS PACING LEADS, EASYTRAK 3 CORONARY SINUS PACING LEADS, ACUITY SPIRAL CORONARY SINUS PACING LEAD
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S391
Decision date: 2015-07-16
Approval order statement: ADD AN AUTOMATED VISION SYSTEM LABEL INSPECTION TO THE FINAL PACKAGING LINE, REMOVE REDUNDANT IN-PROCESS INSPECTION AND MOVE UPSTREAM VALIDATED INSPECTIONS TO A DOWNSTREAM STEP.

Current openFDA PMA Record#

Device: EASYTRAK 2 CORONARY SINUS PACING LEADS, EASYTRAK 3 CORONARY SINUS PACING LEADS, ACUITY SPIRAL CORONARY SINUS PACING LEAD
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S391
Decision date: 2015-07-16
Decision code: OK30
Date received: 2015-06-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADD AN AUTOMATED VISION SYSTEM LABEL INSPECTION TO THE FINAL PACKAGING LINE, REMOVE REDUNDANT IN-PROCESS INSPECTION AND MOVE UPSTREAM VALIDATED INSPECTIONS TO A DOWNSTREAM STEP.