PMA P940031S007

Device: VIGOR(TM) DR PACEMAKER SYSTEM
Applicant: Boston Scientific
PMA number: P940031
Supplement: S007
Decision date: 1997-01-14
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085. THIS SUPPLEMENT QUALIFIED FOR REVIEW UNDER THE PMA SUPPLEMENT PILOT DESCRIBED IN THE MARCH 20, 1996 "DEAR PRESIDENT OR CEO" LETTER REGARDING CHANGES IN MANUFACTURING SITES.

Current openFDA PMA Record#

Device: VIGOR(TM) DR PACEMAKER SYSTEM
Applicant: Boston Scientific
PMA number: P940031
Supplement: S007
Decision date: 1997-01-14
Decision code: APPR
Date received: 1996-11-20
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085. THIS SUPPLEMENT QUALIFIED FOR REVIEW UNDER THE PMA SUPPLEMENT PILOT DESCRIBED IN THE MARCH 20, 1996 "DEAR PRESIDENT OR CEO" LETTER REGARDING CHANGES IN MANUFACTURING SITES.