PMA P950001S008

Device: ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD
Applicant: Boston Scientific
PMA number: P950001
Supplement: S008
Product code: DTB
Decision date: 2000-09-25
Generic name: permanent pacemaker Electrode
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT AN ALTERNATE FACILITY FOR STERILIZATION, PACKAGING AND LABELING AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO.

Current openFDA PMA Record#

Device: ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD
Applicant: Boston Scientific
PMA number: P950001
Supplement: S008
Product code: DTB
Generic name: permanent pacemaker Electrode
Decision date: 2000-09-25
Decision code: APPR
Date received: 2000-08-21
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT AN ALTERNATE FACILITY FOR STERILIZATION, PACKAGING AND LABELING AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO.