PMA P840068S030

Device: VIGOR MODEL 2880 SOFTWARE APPLICATION
Applicant: Boston Scientific
PMA number: P840068
Supplement: S030
Product code: LWP
Decision date: 1996-11-12
Classification: Implantable Pulse Generator, Pacemaker (non-crt)
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - (THIS PMA WAS REVIEWED UNDER THE PMA SUPPLEMENT PILOT PROGRAM THIS APPROVAL APPLIES ONLY TO THE NEW STERILIZATION SITE)

Current openFDA PMA Record#

Device: VIGOR MODEL 2880 SOFTWARE APPLICATION
Applicant: Boston Scientific
PMA number: P840068
Supplement: S030
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
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 PMA WAS REVIEWED UNDER THE PMA SUPPLEMENT PILOT PROGRAM THIS APPROVAL APPLIES ONLY TO THE NEW STERILIZATION SITE)