PMA P050023S154

Device: PSW 2100.U and NEO 2100.U
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S154
Product code: MRM
Decision date: 2021-04-30
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: Approval for updates to programmer software to versions PSW 2100.U and NEO 2100.U to reduce the number of capacitor reformations and move the timepoint for capacitor reformations from overnight to daytime for various Biotronik implantable cardiac devices.

Current openFDA PMA Record#

Device: PSW 2100.U and NEO 2100.U
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S154
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2021-04-30
Decision code: APPR
Date received: 2021-03-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for updates to programmer software to versions PSW 2100.U and NEO 2100.U to reduce the number of capacitor reformations and move the timepoint for capacitor reformations from overnight to daytime for various Biotronik implantable cardiac devices.