PMA P990001S064

Device: VITATRON
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S064
Product code: NVZ
Decision date: 2010-05-11
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE. THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.

Current openFDA PMA Record

Device: VITATRON
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S064
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2010-05-11
Decision code: APPR
Date received: 2010-03-01
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE. THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.