PMA P960013S009

Device: TENDRIL SDX
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S009
Product code: DTB
Decision date: 2000-12-07
Classification: Permanent Pacemaker Electrode
Generic name: permanent pacemaker Electrode
Approval order statement: APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE SUTURE SLEEVES USED WITH THE PACEMAKER LEADS: THE INCORPORATION OF TITANIUM DIOXIDE INTO THE SUTURE SLEEVE MATERIAL TO MAKE THE MATERIAL "MORE VISIBLE DURING IMPLANT"; INCREASING THE INNER DIAMETER OF THE SLEEVE AND; REMOVEL OF THE SLEEVE EYELET'S.

Current openFDA PMA Record#

Device: TENDRIL SDX
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S009
Product code: DTB
Generic name: permanent pacemaker Electrode
Decision date: 2000-12-07
Decision code: APPR
Date received: 2000-11-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE SUTURE SLEEVES USED WITH THE PACEMAKER LEADS: THE INCORPORATION OF TITANIUM DIOXIDE INTO THE SUTURE SLEEVE MATERIAL TO MAKE THE MATERIAL "MORE VISIBLE DURING IMPLANT"; INCREASING THE INNER DIAMETER OF THE SLEEVE AND; REMOVEL OF THE SLEEVE EYELET'S.