PMA P950001S006

Device: IS-1 CONNECTOR TERMINAL OF SELUTE/PICOTIP BIPOLAR LEADS
Applicant: Boston Scientific
PMA number: P950001
Supplement: S006
Product code: DTB
Decision date: 2000-05-19
Generic name: permanent pacemaker Electrode
Approval order statement: Approval for: 1) use of a new mechanically interlocking component design to connect the terminal pin to the terminal ring, and 2) use of a shorter IS-1 connector terminal.

Current openFDA PMA Record#

Device: IS-1 CONNECTOR TERMINAL OF SELUTE/PICOTIP BIPOLAR LEADS
Applicant: Boston Scientific
PMA number: P950001
Supplement: S006
Product code: DTB
Generic name: permanent pacemaker Electrode
Decision date: 2000-05-19
Decision code: APPR
Date received: 2000-04-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for: 1) use of a new mechanically interlocking component design to connect the terminal pin to the terminal ring, and 2) use of a shorter IS-1 connector terminal.