PMA P900070S027

Device: TRILOGY/SOLUS II/PARAGON III/PHOENIX III
Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
PMA number: P900070
Supplement: S027
Product code: KRG
Decision date: 2000-09-07
Classification: Programmer, Pacemaker
Generic name: Programmer, pacemaker
Approval order statement: APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY ST STERIS ISOMEDIX, MINNEAPOLIS, MN.

Current openFDA PMA Record#

Device: TRILOGY/SOLUS II/PARAGON III/PHOENIX III
Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
PMA number: P900070
Supplement: S027
Product code: KRG
Generic name: Programmer, pacemaker
Decision date: 2000-09-07
Decision code: APPR
Date received: 2000-08-11
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY ST STERIS ISOMEDIX, MINNEAPOLIS, MN.