PMA P960013S015

Device: TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S015
Product code: DTB
Decision date: 2006-02-07
Generic name: permanent pacemaker Electrode
Approval order statement: APPROVAL FOR THE TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES TENDRIL ST MODEL 1788 T, TENDRIL ST MODEL 1788TC, AND TENDRIL ST MODEL 1782TC. THE TENDRIL ST MODEL 1788 LEAD IS DESIGNED FOR PERMANENT SENSING IN EITHER THE RIGHT ATRIUM OR THE RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR. THE TENDRIL ST MODEL 1782 LEAD IS DESIGNED FOR PERMANENT SENSING AND PACING IN THE RIGHT ATRIUM, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.

Current openFDA PMA Record#

Device: TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S015
Product code: DTB
Generic name: permanent pacemaker Electrode
Decision date: 2006-02-07
Decision code: APPR
Date received: 2005-12-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES TENDRIL ST MODEL 1788 T, TENDRIL ST MODEL 1788TC, AND TENDRIL ST MODEL 1782TC. THE TENDRIL ST MODEL 1788 LEAD IS DESIGNED FOR PERMANENT SENSING IN EITHER THE RIGHT ATRIUM OR THE RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR. THE TENDRIL ST MODEL 1782 LEAD IS DESIGNED FOR PERMANENT SENSING AND PACING IN THE RIGHT ATRIUM, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.