PMA P950001S009

Device: SELUTE LEADS AND ACCESSORIES
Applicant: Boston Scientific
PMA number: P950001
Supplement: S009
Product code: DTB
Decision date: 2002-12-13
Generic name: permanent pacemaker Electrode
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.

Current openFDA PMA Record#

Device: SELUTE LEADS AND ACCESSORIES
Applicant: Boston Scientific
PMA number: P950001
Supplement: S009
Product code: DTB
Generic name: permanent pacemaker Electrode
Decision date: 2002-12-13
Decision code: OK30
Date received: 2002-11-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.