PMA P820018S063

Device: AUTIMA/AURORA CARDIAC PACING SYSTEM
Applicant: St. Jude Medical, Inc.
PMA number: P820018
Supplement: S063
Product code: LWP
Decision date: 1996-07-23
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: APPROVAL FOR A CHANGE IN STERILIZATION CONTRACTOR. THE PROPOSED STERILIZATION CONTRACTOR IS:GRIFFITH MICRO SCIENCE, INC., 2973 OLYMPIC INDUSTRIAL DRIVE, SMYRNA, GA 30080-7322

Current openFDA PMA Record

Device: AUTIMA/AURORA CARDIAC PACING SYSTEM
Applicant: St. Jude Medical, Inc.
PMA number: P820018
Supplement: S063
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 1996-07-23
Decision code: APPR
Date received: 1994-07-05
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN STERILIZATION CONTRACTOR. THE PROPOSED STERILIZATION CONTRACTOR IS:GRIFFITH MICRO SCIENCE, INC., 2973 OLYMPIC INDUSTRIAL DRIVE, SMYRNA, GA 30080-7322