PMA P940031S006

Device: VIGOR(TM) DR PACEMAKER SYSTEM
Applicant: Boston Scientific
PMA number: P940031
Supplement: S006
Decision date: 1996-11-12
Approval order statement: ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT WAS REVIEWED UNDER THE PILOT PROGRAM AND THE APPROVAL APPLIES ONLY TO THE REQUEST FOR A NEW STERILIZATION FACILITY

Current openFDA PMA Record#

Device: VIGOR(TM) DR PACEMAKER SYSTEM
Applicant: Boston Scientific
PMA number: P940031
Supplement: S006
Decision date: 1996-11-12
Decision code: APPR
Date received: 1996-10-16
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT WAS REVIEWED UNDER THE PILOT PROGRAM AND THE APPROVAL APPLIES ONLY TO THE REQUEST FOR A NEW STERILIZATION FACILITY