PMA P950001S001

Device: SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
Applicant: Boston Scientific
PMA number: P950001
Supplement: S001
Product code: DTB
Decision date: 1996-11-12
Generic name: permanent pacemaker Electrode
Approval order statement: ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT REVIEWED UNDER THE PILOT PROGRAM AND THE APPROVAL ONLY APPLIES TO THE REQUEST FOR A NEW STERILIZATION SITE

Current openFDA PMA Record#

Device: SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
Applicant: Boston Scientific
PMA number: P950001
Supplement: S001
Product code: DTB
Generic name: permanent pacemaker Electrode
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 REVIEWED UNDER THE PILOT PROGRAM AND THE APPROVAL ONLY APPLIES TO THE REQUEST FOR A NEW STERILIZATION SITE