PMA P990001S122

Device: Diva family(includes Diamond II, Ruby II, Topaz II, Jade II, Vita DDDR, Vita DDD and Vita VVIR) Dema family, Selection A
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S122
Product code: NVZ
Decision date: 2016-09-06
Generic name: Pulse generator, permanent, implantable
Approval order statement: Approval for enhancements to the Medtronic Model SW028 Baseline Operating System Software (BOSS) as well as the Vitatron Model VSH04 Desktop Application software running on the CareLink Encore 29901 Programmer.

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, Selection A
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S122
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2016-09-06
Decision code: APPR
Date received: 2016-06-24
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for enhancements to the Medtronic Model SW028 Baseline Operating System Software (BOSS) as well as the Vitatron Model VSH04 Desktop Application software running on the CareLink Encore 29901 Programmer.