PMA P990001S120

Device: APPLICATION SOFTWARE, PROVIT SOFTWARE, VITATRON C20 SR IPG, VITATRON C60 DR IPG, VITATRON T20 SR IPG, VITATRON T60 DR
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S120
Product code: NVZ
Decision date: 2015-06-04
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.

Current openFDA PMA Record

Device: APPLICATION SOFTWARE, PROVIT SOFTWARE, VITATRON C20 SR IPG, VITATRON C60 DR IPG, VITATRON T20 SR IPG, VITATRON T60 DR
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S120
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2015-06-04
Decision code: APPR
Date received: 2015-04-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.