PMA P990001S118

Device: DIVA FAMILY (INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE II, VITA DDDR, VITA DDD AND VITA VVIR) DEMA FAMILY (INCLUDES
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S118
Product code: NVZ
Decision date: 2014-09-05
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.

Current openFDA PMA Record

Device: DIVA FAMILY (INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE II, VITA DDDR, VITA DDD AND VITA VVIR) DEMA FAMILY (INCLUDES
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S118
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2014-09-05
Decision code: APPR
Date received: 2014-07-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.